Diabetic Foot Ulcer (DFU)Phase 1NCT07498218
Phase 1 Study of VELGRAFT, a Living Cellular Construct, in the Management of Chronic Diabetic Foot Ulcers Which Have Attained Granulation Tissue
A Phase 1 study testing an allogenic cell-based product, containing living human bone marrow-derived mesenchymal stem cells (MSCs) and MSCs differentiated into adipocytes on a porous chitosan-gelatin matrix in people with Diabetic Foot Ulcer (DFU) and Granulation of Chronic Diabetic Wounds, run by Ayu, Inc. at 1 site in United States.
Trial summary
The objective of this study is to evaluate the safety and efficacy of VELGRAFT in patients with chronic diabetic foot ulcers, which have attained granulation tissue. VELGRAFT will be studied in conjunction with pest practices for diabetic foot ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer (DFU), Granulation of Chronic Diabetic Wounds
- What is being tested?
- an allogenic cell-based product, containing living human bone marrow-derived mesenchymal stem cells (MSCs) and MSCs differentiated into adipocytes on a porous chitosan-gelatin matrix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2026to 13 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Patient has current diagnosis of type 1 or type 2 diabetes mellitus
- Patient's ulcer has been present for greater than 4 weeks and less than 24 weeks at the screening visit
- Patient's foot ulcer located below malleoli and is between 1-20 cm2 in size on day 1
- Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days:
- Dorsum transcutaneous oxygen test (TcPO2) with results ≥ 30mmHg, OR ii. ABIs (Ankle brachial index) with results of ≥0.7 and ≤1.2, OR iii. Doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected leg
Show all 9Show fewer
- For female patients of childbearing potential, commitment to using a medically accepted means of birth control (i.e., oral, transdermal, or implanted contraceptives, intrauterine device, diaphragm, condom, abstinence, or surgical sterility) throughout study period and tests negative on a pregnancy test
- Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule (Grade 1 by Wagner's scale or Grade A-I by University of Texas Staging System), that has not shown signs of healing despite standard treatment
- Able and willing to wear an off-loading device or orthopedic shoe
Who cannot join
- Gangrene is present on any part of the affected foot
- Ulcer is of non-diabetic pathophysiology
- Patient's ulcer is over a Charcot deformity
- Ulcer total surface area > 20 cm2
- Osteomyelitis, cellulitis, or other evidence of infection
- Patient is currently being treated, or received treatment within one month prior, with chemotherapeutic agents, immunosuppressive agents, radiation therapy, or corticosteroids
Show all 16Show fewer
- Patient has AIDS, HIV, or cardiac (ejection fraction less than 50% on 2D-ECHO; t-wave inversion on ECG), endocrine (hypothyroidism), disease, or present symptoms/complaints suggestive of gastrointestinal, neurological, or immune disease, that in the opinion of the Investigator, would make the patient an inappropriate candidate for this wound healing study.
- Patient with any of the below physiological parameters:
- BP systolic >140 or <90 mmHg or diastolic >90 or <60mmHg ii. Pulse <60 or >100bpm iii. Respiratory Rate <9 and >20 bpm iv. Pulse Oximetry <94% in room air v. Temp >100.4 degrees Fahrenheit vi. ALT and AST >2 times the upper limit of normal (ULN) vii. Abnormal bilirubin unless subject has Gilbert's viii. eGFR <60 mL/min/1.73 m2 by CKD-EPI ix. Platelet Count <100,000 x. HbA1c: ≥8.5% xi. Hemoglobin: ≤10g/dL
- Patients presenting with an ulcer probing to the bone (UT Grade IIIA-D).
- Patients with Wagner Grades 2-6 ulcers.
- Patient has had a previous lower extremity amputation.
- Received allograft, autograft, xenograft, or cellular therapy within 30 days of screening
- Female patients who are nursing, pregnant, or planning on becoming pregnant during the study period.
- Patient is unwilling or unable to comply with the postoperative visits necessary for data collection.
- Patients with known hypersensitivity to the components of the product or shipping medium.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Deepa Arora, M.D. contact
United States1 site, 1 recruiting
- Recruiting
Advanced Foot Care
Phoenix, Arizona, 85032
Krishna Sai Clinical Research Manager, 857-891-3039, kspenumarthi@axentrabio.com
Jaminelli Banks
About this study
Official title: A Prospective, Multi-center, Randomized, Double-blind, Controlled, Phase 1 Study of VELGRAFT, a Living Cellular Construct, in the Management of Chronic Diabetic Foot Ulcers Which Have Attained Granulation Tissue
The objective of this study is to evaluate the safety and efficacy of VELGRAFT in patients with chronic diabetic foot ulcers, which have attained granulation tissue. VELGRAFT will be studied in conjunction with pest practices for diabetic foot ulcers. The Primary goal is to assess the safety of VELGRAFT to treat diabetic foot ulcers as compared to standard of care therapy. Secondary goals include the assessment of efficacy of VELGRAFT for healing diabetic foot ulcers compared to standard of care therapy
Read the detailed description
This phase I study is a prospective, randomized, double-blind, active controlled study in up to 24 patients. The study will be conducted in 2 parts: Part A will include 12 patients in a dose escalation scheme to identify the maximum tolerated application of VELGRAFT (up to 4 cohorts, with 3 patients in each cohort), and Part B will include 12 or more patients randomized 1:1 between the VELGRAFT (with the number of applications based on Part A) and control arms. If dose escalation stops prior to Cohort 4 in Part A, meaning less than 12 patients are enrolled in Part A, then the number of patients in Part B will be increased accordingly. For example, if dose escalation stops after Cohort 3 for Part A (i.e., 9 subjects enrolled in Part A), then Part B will include 14 patients (as an even number of patients is needed for 1:1 randomization), for a total of 23 patients in the Phase I study. For all patients, the treatment phase is a 12-week period, in which VELGRAFT or a standard moist dressing will be applied weekly to the DFU. After the treatment phase, there is a final follow-up at 24 weeks. Subject participation is expected to last up to 183 days.
In Part A, eligible patients will enter into the dose escalation scheme, which will include 4 cohorts. Patients in Cohort 1 will receive a total of one application of VELGRAFT, in Cohort 2 will receive a total of two applications of VELGRAFT, in Cohort 3 will receive a total of three applications of VELGRAFT, and in Cohort 4 will receive a total of 4 applications of VELGRAFT.
Three subjects in each cohort will be treated with VELGRAFT based on the escalation scheme as defined below. All the subjects enrolled in a cohort will be monitored continuously for adverse events. The subjects in each cohort will be enrolled in a staggered manner, with a staggering interval of 14 days between subjects to allow for adequate capture of any safety signals.
Decisions to escalate to the next cohort will follow the steps as defined below. Escalations will occur sequentially and after safety is established in the preceding cohort. Enrollment into subsequent cohorts will proceed only after the current cohort has completed 7 days of study treatment and there have been no DLTs or other safety signals observed in the treated patients.
The maximum tolerated application will be the cohort at which no more than one subject experiences a DLT. If 1 subject enrolled in a cohort of 3 experiences a DLT, escalation will be stopped and this level will be considered the maximum tolerated application. If 2 subjects enrolled in a cohort of 3 experience a DLT, the maximum tolerated application will have been exceeded, and the next lower level will be considered the maximum tolerated application. Once the maximum tolerated application is reached, escalation will be stopped. If the maximum tolerated application is not reached even with the highest number of applications, Part A of the study will be stopped and there will be no further escalation.
In this study, a DLT will be defined as the occurrence of any of the following within 7 days from study drug administration using National Cancer Institute Common Terminology Criteria for adverse Events (NCI CTCAE) version 5.0 criteria, whether related or not to the study treatment.
Dose limiting toxicities:
- Grade 3 or higher hypersensitivity reactions
- Grade 3 or higher rash
- Grade 2 or higher skin infection
- Any death, except for any death that has been determined by the investigator as unrelated (clearly not related) to the investigational treatment.
In Part B of the study, 12 or more patients will be randomized 1:1 between the VELGRAFT treatment arm and control arm. The number of VELGRAFT treatments will be one less application than the maximum tolerated application identified in Part A. For example, if the maximum tolerated application is four (4) applications (one application per week, for 4 consecutive weeks), then the VELGRAFT treatment arm in Part B will include three (3) applications. However, if the maximum tolerated application is one (1) application, then the VELGRAFT treatment arm in Part B will be one (1) application.
- Being tested
- an allogenic cell-based product, containing living human bone marrow-derived mesenchymal stem cells (MSCs) and MSCs differentiated into adipocytes on a porous chitosan-gelatin matrix, Standard of Care of Diabetic Foot Ulcers
- Keywords
- Diabetic Foot Ulcers, VELGRAFT
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
an allogenic cell-based product, containing living human bone marrow-derived mesenchymal stem cells (MSCs) and MSCs differentiated into adipocytes on a porous chitosan-gelatin matrixDrug
Also called VELGRAFT
VELGRAFT is applied topically. Cells used in VELGRAFT are derived from bone marrow from an FDA-registered establishment. The MSCs in VELGRAFT have been tested for the human leukocyte antigen-2 (HLA-2) marker to minimize rejection due to an immune response by the patient and has undergone a battery of biocompatibility testing. Additionally, cells contained in VELGRAFT are cultured in xenogeneic-free medium, reducing risk of sensitivity to animal products. VELGRAFT is considered a combination product, with both biologic and device constituents
Standard of Care of Diabetic Foot UlcersOther
Standard of Care includes Moist Wound Dressing
| Study group | Role | What they receive |
|---|---|---|
| Investigational Product | Experimental | Subject receives applications of VELGRAFT Receives: Drug: an allogenic cell-based product, containing living human bone marrow-derived mesenchymal stem cells (MSCs) and MSCs differentiated into adipocytes on a porous chitosan-gelatin matrix |
| Control Group | Active comparator | Subject receives Standard of Care treatment Receives: Other: Standard of Care of Diabetic Foot Ulcers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
To assess the safety of VELGRAFT to treat DFUs as compared to standard of care therapy through the difference between the VELGRAFT IP and the control groups for all treated patients in the proportion of patients reporting adverse events during the active study period. The investigator will assess the relationship between study therapy and the occurence of each AE/SAE and will use clinical judgment to determine if there is a reasonable possibility that the IP was responsible for the AE/SAE being reported. Determination of relatedness to the IP will be defined according to one of the following categories:
- Definite - The AE/SAE is clearly related to the IP
- Probable - The AE/SAE is likely related to the IP
- Possible - The AE/SAE may be related to the IP
- Unlikely - The AE/SAE is doubtfully related to the IP
- Unrelated - The AE/SAE is clearly NOT related to the IP AE/SAE's will be assessed by CTCAE Version 5.0 and safety data of the study will be evaluated by an independent DSMB.
Measured: From Enrollment to End of Follow-Up at 169 days
Secondary outcomes (7)
Efficacy of VELGRAFT
To assess the efficacy of VELGRAFT for healing DFUs compared to standard of care therapy. This will be assessed by the difference between the two treatment arms in the proportion of participants with complete wound closure at week 12 and 14. Complete wound closure is defined as complete skin re-epithelialization without drainage or dressing requirements, confirmed at two consecutive study visits, Week 12 and 14. Wounds will be measured by Imito Wound Measurement Software.
Measured: From Enrollment to weeks 14
Wound Closure Rate
To Evaluate wound closure rate over the course of the trial. This will be measured by the proportion of participants with complete wound closure by 24 weeks.
Measured: From Enrollment to 24 weeks
Ulcer Recurrence Rate
To measure ulcer recurrence rate over the course of the trial
Measured: Enrollment through study completion at an average of 169 days.
Assess Re-epithelialization
to Assess Re-epithelialization over the course of the Trial
Measured: From Enrollment through study completion, an average of 169 days
Assess scar by scar scales
To Assess scar by scar scales via the Patient and Observer Scar Assessment Scale. The Patient and Observer Scar Assessment scale is a 5-point scale. The lowest score is '1', which corresponds to the situation of normal skin (i.e. normal pigmentation, no itching). Score 5 equals the largest difference from normal skin (i.e. the worst imaginable scar or sensation).
Measured: Enrollment through study completion, an average of 169 days
Assess Quality of Life
To Assess patient reported outcomes for quality of life via patient reported outcomes. Patient reported outcomes include the Wound Pain Visual Analogue Scale and the pruritus Visual Analogue Scale which share a common unit of measurement. The Wound Pain Visual Analogue Scale is a 10-cm (100-mm) straight line, anchored by "no pain" (0) and "worst imaginable pain" (10 or 100 mm), used to objectively measure subjective pain intensity. Patients mark the line to indicate pain levels, with higher scores indicating higher severity and a need for intervention. The Pruritus Visual Analog Scale (VAS) is a validated, subjective 10-cm (100-mm) linear tool used to measure itch intensity, ranging from "no pruritus" (0) to "worst imaginable itch" (10 cm). Patients or owners mark the line to indicate severity, which is then measured to quantify intensity, often categorized as Mild, Moderate, or Severe.
Measured: From Enrollment through study completion, an average of 169 days.
Assess Quality of Life
To Assess patient reported outcomes for quality of life via patient reported outcomes. Patient reported outcomes include the SF-36 questionnaire, a widely used, self-reported, 36-question survey that measures physical and mental health-related quality of life over the past four weeks. Covering eight health domains, it evaluates functioning, well-being, and limitations, providing scores that, when higher, indicate better health.
Measured: From screening through study completion, an average of 169 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start11 Mar 2026
- Primary completion13 Oct 2026 (estimated)
- Study completion13 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot Ulcer (DFU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A prospective, multi-center, randomized, double-blind, controlled, Phase 1 study of VELGRAFT
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ayu, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498218
- Sponsor's protocol ID
- Ayu / P01-2019 / CT/ VG
- Status last verified
- Aug 2026
- First submitted
- 13 Feb 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Any intellectual property rights arising from this study shall fully belong to the sponsor. The sponsor may publish and disseminate the results of the study. This study represents a joint effort between Sponsor and Investigators, and as such, the parties agree that the recommendation of any party concerning manuscripts or text shall be taken into consideration in the preparation of final scientific documents for publication or presentation. All proposed publications and presentations will be reviewed jointly by sponsor and investigator/s. If investigator/s wish to publish or present the study or a part there of, such publications will be submitted to the sponsor for review and approval prior to submission for publication or presentation. If any such proposed publication or presentation contains patentable subject matter which in sponsor's sole discretion, warrants intellectual proprietary protection, sponsor may, at its sole discretion delete any part of the proposed publication
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized, Double-blind, Controlled, Phase 1 Study of VELGRAFT, a Living Cellular Construct, in the Management of Chronic Diabetic Foot Ulcers Which Have Attained Granulation Tissue
- ClinicalTrials.gov ID
- NCT07498218
- Acronym / sponsor ID
- Ayu / P01-2019 / CT/ VG
- Keywords
- Diabetic Foot Ulcers, VELGRAFT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Ayu, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- 13 Oct 2026 (estimated)
- Study completion
- 13 Oct 2026 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the safety and efficacy of VELGRAFT in patients with chronic diabetic foot ulcers, which have attained granulation tissue. VELGRAFT will be studied in conjunction with pest practices for diabetic foot ulcers. The Primary goal is to assess the safety of VELGRAFT to treat diabetic foot ulcers as compared to standard of care therapy. Secondary goals include the assessment of efficacy of VELGRAFT for healing diabetic foot ulcers compared to standard of care therapy
Detailed description
This phase I study is a prospective, randomized, double-blind, active controlled study in up to 24 patients. The study will be conducted in 2 parts: Part A will include 12 patients in a dose escalation scheme to identify the maximum tolerated application of VELGRAFT (up to 4 cohorts, with 3 patients in each cohort), and Part B will include 12 or more patients randomized 1:1 between the VELGRAFT (with the number of applications based on Part A) and control arms. If dose escalation stops prior to Cohort 4 in Part A, meaning less than 12 patients are enrolled in Part A, then the number of patients in Part B will be increased accordingly. For example, if dose escalation stops after Cohort 3 for Part A (i.e., 9 subjects enrolled in Part A), then Part B will include 14 patients (as an even number of patients is needed for 1:1 randomization), for a total of 23 patients in the Phase I study. For all patients, the treatment phase is a 12-week period, in which VELGRAFT or a standard moist dressing will be applied weekly to the DFU. After the treatment phase, there is a final follow-up at 24 weeks. Subject participation is expected to last up to 183 days.
In Part A, eligible patients will enter into the dose escalation scheme, which will include 4 cohorts. Patients in Cohort 1 will receive a total of one application of VELGRAFT, in Cohort 2 will receive a total of two applications of VELGRAFT, in Cohort 3 will receive a total of three applications of VELGRAFT, and in Cohort 4 will receive a total of 4 applications of VELGRAFT.
Three subjects in each cohort will be treated with VELGRAFT based on the escalation scheme as defined below. All the subjects enrolled in a cohort will be monitored continuously for adverse events. The subjects in each cohort will be enrolled in a staggered manner, with a staggering interval of 14 days between subjects to allow for adequate capture of any safety signals.
Decisions to escalate to the next cohort will follow the steps as defined below. Escalations will occur sequentially and after safety is established in the preceding cohort. Enrollment into subsequent cohorts will proceed only after the current cohort has completed 7 days of study treatment and there have been no DLTs or other safety signals observed in the treated patients.
The maximum tolerated application will be the cohort at which no more than one subject experiences a DLT. If 1 subject enrolled in a cohort of 3 experiences a DLT, escalation will be stopped and this level will be considered the maximum tolerated application. If 2 subjects enrolled in a cohort of 3 experience a DLT, the maximum tolerated application will have been exceeded, and the next lower level will be considered the maximum tolerated application. Once the maximum tolerated application is reached, escalation will be stopped. If the maximum tolerated application is not reached even with the highest number of applications, Part A of the study will be stopped and there will be no further escalation.
In this study, a DLT will be defined as the occurrence of any of the following within 7 days from study drug administration using National Cancer Institute Common Terminology Criteria for adverse Events (NCI CTCAE) version 5.0 criteria, whether related or not to the study treatment.
Dose limiting toxicities:
- Grade 3 or higher hypersensitivity reactions
- Grade 3 or higher rash
- Grade 2 or higher skin infection
- Any death, except for any death that has been determined by the investigator as unrelated (clearly not related) to the investigational treatment.
In Part B of the study, 12 or more patients will be randomized 1:1 between the VELGRAFT treatment arm and control arm. The number of VELGRAFT treatments will be one less application than the maximum tolerated application identified in Part A. For example, if the maximum tolerated application is four (4) applications (one application per week, for 4 consecutive weeks), then the VELGRAFT treatment arm in Part B will include three (3) applications. However, if the maximum tolerated application is one (1) application, then the VELGRAFT treatment arm in Part B will be one (1) application.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, multi-center, randomized, double-blind, controlled, Phase 1 study of VELGRAFT
| Arm | Type | Receives |
|---|---|---|
| Investigational Product | Experimental | Drug: an allogenic cell-based product, containing living human bone marrow-derived mesenchymal stem cells (MSCs) and MSCs differentiated into adipocytes on a porous chitosan-gelatin matrixSubject receives applications of VELGRAFT |
| Control Group | Active comparator | Other: Standard of Care of Diabetic Foot UlcersSubject receives Standard of Care treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years
- Patient has current diagnosis of type 1 or type 2 diabetes mellitus
- Patient's ulcer has been present for greater than 4 weeks and less than 24 weeks at the screening visit
- Patient's foot ulcer located below malleoli and is between 1-20 cm2 in size on day 1
- Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days:
Key exclusion criteria (16 listed)
- Gangrene is present on any part of the affected foot
- Ulcer is of non-diabetic pathophysiology
- Patient's ulcer is over a Charcot deformity
- Ulcer total surface area > 20 cm2
- Osteomyelitis, cellulitis, or other evidence of infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| an allogenic cell-based product, containing living human bone marrow-derived mesenchymal stem cells (MSCs) and MSCs differentiated into adipocytes on a porous chitosan-gelatin matrixAlso: VELGRAFTVELGRAFT is applied topically. Cells used in VELGRAFT are derived from bone marrow from an FDA-registered establishment. The MSCs in VELGRAFT have been tested for the human leukocyte antigen-2 (HLA-2) marker to minimize rejection due to an immune response by the patient and has undergone a battery of biocompatibility testing. Additionally, cells contained in VELGRAFT are cultured in xenogeneic-free medium, reducing risk of sensitivity to animal products. VELGRAFT is considered a combination product, with both biologic and device constituents | Drug | Investigational Product |
| Standard of Care of Diabetic Foot UlcersStandard of Care includes Moist Wound Dressing | Other | Control Group |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: From Enrollment to End of Follow-Up at 169 days
To assess the safety of VELGRAFT to treat DFUs as compared to standard of care therapy through the difference between the VELGRAFT IP and the control groups for all treated patients in the proportion of patients reporting adverse events during the active study period. The investigator will assess the relationship between study therapy and the occurence of each AE/SAE and will use clinical judgment to determine if there is a reasonable possibility that the IP was responsible for the AE/SAE being reported. Determination of relatedness to the IP will be defined according to one of the following categories: * Definite - The AE/SAE is clearly related to the IP * Probable - The AE/SAE is likely related to the IP * Possible - The AE/SAE may be related to the IP * Unlikely - The AE/SAE is doubtfully related to the IP * Unrelated - The AE/SAE is clearly NOT related to the IP AE/SAE's will be assessed by CTCAE Version 5.0 and safety data of the study will be evaluated by an independent DSMB.
7 secondary outcomes
Efficacy of VELGRAFT
Time frame: From Enrollment to weeks 14
Wound Closure Rate
Time frame: From Enrollment to 24 weeks
Ulcer Recurrence Rate
Time frame: Enrollment through study completion at an average of 169 days.
Assess Re-epithelialization
Time frame: From Enrollment through study completion, an average of 169 days
Assess scar by scar scales
Time frame: Enrollment through study completion, an average of 169 days
Assess Quality of Life
Time frame: From Enrollment through study completion, an average of 169 days.
Assess Quality of Life
Time frame: From screening through study completion, an average of 169 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No. Any intellectual property rights arising from this study shall fully belong to the sponsor. The sponsor may publish and disseminate the results of the study. This study represents a joint effort between Sponsor and Investigators, and as such, the parties agree that the recommendation of any party concerning manuscripts or text shall be taken into consideration in the preparation of final scientific documents for publication or presentation. All proposed publications and presentations will be reviewed jointly by sponsor and investigator/s. If investigator/s wish to publish or present the study or a part there of, such publications will be submitted to the sponsor for review and approval prior to submission for publication or presentation. If any such proposed publication or presentation contains patentable subject matter which in sponsor's sole discretion, warrants intellectual proprietary protection, sponsor may, at its sole discretion delete any part of the proposed publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Deepa Arora, M.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing an allogenic cell-based product, containing living human bone marrow-derived mesenchymal stem cells (MSCs) and MSCs differentiated into adipocytes on a porous chitosan-gelatin matrix in people with Diabetic Foot Ulcer (DFU) and Granulation of Chronic Diabetic Wounds, run by Ayu, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Deepa Arora (+917738804988, info@clinexel.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: From Enrollment to End of Follow-Up at 169 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.