Diabetic Foot UlcerPhase 2NCT06810726
Evaluate Use of Tropocells(R) Autologous Platelet-rich Fibrin (PRF) for Wagner Grade 1 and Grade 2, Mild to Mod Neuroischemic Plantar Diabetic Foot Ulcer Wound Care.
A Phase 2 study testing Platelet Rich Plasma in people with Diabetic Foot Ulcer and Type 1 Diabetes Mellitus, run by Estar Medical dba Medical Technologies, LTD at 2 sites in United States.
Trial summary
The goal of this investigational study is to evaluate the safety and clinical performance of Tropocells Autologous Platelet-rich Fibrin (PRF) for wound care for both males and females, ages 18-80 years old, with Grade 1 and 2, mild to moderate, neuroischemic diabetic chronic foot ulcers in subjects with Type 1 and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot Ulcer, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Platelet Rich Plasma
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Apr 2025to 15 Aug 2026
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years of age
- Type 1 or Type 2 Diabetes
- Grade 2, DFU, non-infected, below the ankle,1.0-12.0 cm2, present ≥ 30 day
- Ulcer Size 1.0 cm2 to 12.0 cm2
- Wound location will be distal to the malleolus, excluding between the toes, with no exposed capsule, tendon, or bone, and no tunneling, undermining, or sinus tracts, a depth of ≤ 5mm
- If more than one non-healing wound is present, the selected ulcer will be the largest and ≥ 1 cm2 in size.
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- At least 2.0 cm between the index wound and other wounds.
- Study ulcer has been present for at least 30 days and has undergone the 14-day
- Adequate vascular perfusion of the affected limb, as defined by at least one of the following: Ankle-Brachial Index (ABI) ≥ 0.65 and ≤ 1.2, Toe Pressure (TP) ≥ 30 mmHg, Transcutaneous partial pressure of oxygen (TcPO2) ≥ 30 mmHg, or skin perfusion pressure (SPP) ≥ 30 mmHg.
- WIFI SCORE- wound grade 1, ischemia grade 0-1, and infection grade 0)
- Screening Period of the standard of care with 20% or less wound closure.
- No Clinical Signs of Infection at the wound site or the affected limb.
- Post-debridement without signs of necrotic tissue.
- Normal Platelet count ≥ 105,000 and <450, 000 (according to CBC)
- Hemoglobin (Hgb) ≥10 g/dL and Hematocrit (HCT) ≥ 27% (according to CBC)
- Controlled glucose level HbA1C ≤ 12%, with active treatment being conducted to reduce the value to by a primary provider or endocrinologist
- No Chronic Renal Failure (CRF); Estimated glomerular filtration rate (eGFR) ≥ 15
- PT/PTT - INR between 2.0-3.0 (with blood thinners).
- Nutritional Status with no severe protein deficiency, Pre-albumen >15 mg/dL
- Demonstrated adequate offloading using DH Walker boot with Plastazote Insole (OR equivalent off-loading device).
- If a female of childbearing potential, must have a negative serum or urine pregnancy test at screening and use contraception or abstinence during trial.
- Male subjects agree to use contraception or abstinence during the trial.
- The subject has provided written informed consent before any screening procedures and agrees to comply with study procedures and requirements.
Who cannot join
- Life expectancy is less than 12 months.
- Anemia Hgb ≤ 10 g/dL and HCT ≤ 27%.
- Ulcers of other than diabetic foot pathophysiology.
- Participation in another clinical trial involving a device or a systematically administered investigational study drug or treatment within 30 days.
- Documented sepsis, proven with blood cultures, within 2 weeks of the trial or during the Screening Phase.
- Soft tissue infection at the designated ulcer or the same extremity within 2 weeks of the time of screening.
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- Osteomyelitis at the designated wound site; using ESR ≥ and /or CRP ≥ 7.9 mg/d as a screen.
- CKD Level G5: Chronic Renal Failure (CRF) sufficient to require dialysis.
- Religious constraints to using blood products, including autologous blood.
- Alcohol or substance abuse (other than tobacco) within 2 months before enrollment.
- Blood-borne or communicable diseases that would likely prevent full participation in the trial (e.g., HIV, AIDs, COVID, TB).
- Participation in another clinical trial involving a device or a systematically administered investigational study drug or treatment within 30 days of initiating the trial.
- The subject has severe lymphedema (Stage 3) where the individual cannot lift the extremity on their own secondary to the amount of edema and fluid weight.
- The subject is undergoing hemodialysis.
- Subjects who are cognitively impaired, unable to understand the informed consent, or have a health care proxy.
- Subjects with sickle cell anemia, thrombocytopenia, leukemia, or blood dyscrasia.
- History of problems with coagulation, abnormal thrombocytes (platelets), or receiving heparin intravenously; subjects taking coumadin, aspirin, clopidogrel, or other oral anti-coagulants are not excluded.
- Anemia where weekly blood draws of 12 or 23 per week may not be tolerated.
- Received electrostimulation, hyperbaric treatments, growth factors, or any cell or tissue-derived therapy for any wounds 30 days before entry into the study.
- Systemic corticosteroids, (except for subjects receiving inhaled corticosteroid treatments for asthma or COPD) 30 days before entry into the study.
- Received within 30 days before the study or scheduled to receive medications or treatments known to interfere with or affect the rate or quality of wound closure (e.g., systemic steroids, immunosuppressive therapy, autoimmune disease therapy within the past 12 months, dialysis, radiation therapy to the treatment area, vascular surgery, angioplasty, or thrombolysis.
- Received radiation therapy or chemotherapy within the previous 3 months.
- Subjects with known sensitivity to blood components such as those in the PRF kit.
- The subject has inadequate venous access for repeated blood draws required for the PRP preparation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
WoundCentrics Wound Care & Hyperbarics -Corpus Christi - Shoreline
Corpus Christi, Texas, 78404
Tarek Ibraham, MBA, 361-371-5544, Tarek.Ibrahim@woundcentrics.com
Lisa Standlee, FNP, 361-371-554, Lisa.Standlee@woundcentrics.com
- Recruiting
Woundcentrics Wound Care Center At Corpus Christi South
Corpus Christi, Texas, 78414
Tarek Ibrahim, MBA, 361-299-0364, Tarek.Ibrahim@woundcentrics.com
Liza Sanchez, FNP, 361-299-0364, Liza.Sanchez@woundcentrics.com
About this study
Official title: EVALUATION OF THE SAFETY AND THE CLINICAL PERFORMANCE IN TREATMENT OF CHRONIC DIABETIC FOOT ULCER, WITH THE TROPOCELLS®, BASED AUTOLOGOUS PLATELET RICH FIBRIN (Tropocells(R) Autologous PRF Systems)
The goal of this investigational study is to evaluate the safety and clinical performance of Tropocells Autologous Platelet-rich Fibrin (PRF) for wound care for both males and females, ages 18-80 years old, with Grade 1 and 2, mild to moderate, neuroischemic diabetic chronic foot ulcers in subjects with Type 1 and Type 2 Diabetes Mellitus. The main question[s] it aims to answer [is/are]:
Measure 1: Wound Closure with Tropocells Autologous PRF System for DFU Measure 2: Safety of Tropocells Autologous PRF System for DFU Researchers will enroll to acquire approximately 30 evaluable subjects with no comparison group.
Read more
Run-In Phase (2 weeks): participants with chronic diabetic foot wounds will undergo a 2-week run in phase presenting to the clinic for weekly visits, for standard of care.
Active Treatment Phase (12 weeks): participants that do not show a reduction of at least 20% may be qualified to advance to the active treatment phase where wounds will be evaluated and treated weekly in the research clinic to receive standard of care with Tropocells Autologous PRF System.
Follow-up Phase (1 month and 3 months): participants with wounds that losed during the Active Treatment Phase ( 100% wound closure with two weekly assessments demonstrating persistent closure) will be advanced to the follow-up phase to show if the wound remains closed at 1 month and 3 months.
Read the detailed description
Run-In Phase (2 weeks): participants with chronic diabetic foot wounds will undergo a 2-week run in phase presenting to the clinic for weekly visits, where they will receive standard of care Including-
- nutritional supplementation for 2 weeks,
- wound assessment with photos and measurements,
- wound care including cleansing and debridement,
- wound dressings,
- mild compression of the lower extremity, and
- off-loading with a removable boot.
Active Treatment Phase (12 weeks): participants that do not show a reduction of at least 20% may be qualified to advance to the active treatment phase where wounds will be evaluated and treated weekly in the research clinic. In addition to standard of care, Tropocells Autologous PRF Systems gel clot will be placed on the wound bed after cleansing and debridement prior to wound dressing and off-loading.
Data will be captured for:
Primary Outcome- Clinical Performance with complete wound closure, and Secondary Outcome(s)-
- Safety assessing adverse events (AE) and severe adverse events (SAE),
- Measures of Clinical Performance including,
- trajectory of wound area reduction
- percent (%) of area reduction,
- proportion of wound area reduction
Follow-up Phase (1 month and 3 months): participants that have 100% wound closure with two weekly assessments demonstrating persistent closure, will be advanced to the follow-up phase, where they will be assessed at 1 month and 3 months with photos and measurements to show if they remain closed.
- Conditions
- Diabetic Foot Ulcer, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus (T2DM), Neuroischemic Foot Ulcer, Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer), Chronic Wound Care
- Being tested
- Platelet Rich Plasma
- Keywords
- PRF used for Wagner Grade 2 DFU, Tropocells Platelet-rich Fibrin, Platelet-rich Plasma (PRP), Platelet-derived Factors for wound care, Chronic Wound Care
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Leg Ulcer, Foot Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich PlasmaDevice
Tropocells(R) Autologous Platelet-Rich Fibrin
| Study group | Role | What they receive |
|---|---|---|
| T1DM,T2DM participants with non-infected, neuroischemic, chronic foot ulcers | Experimental | During Screen-the participant will be treated with standard of care (SOC) for 2 weeks, including education, nutritional supplement, weekly wound assessments and care with off-loading. After the two weekly visits, subjects who meet the inclusion/exclusion criterion, show adequate perfusion and area reduction less than 20%, and comply with the standard of care will be enrolled in the Active Treatment Phase. During the Active Treatment Phase, subjects will be treated weekly with TropoCells® Autologous Platelet-rich Fibrin (PRF) for twelve (12) weeks and continued SOC. Wound area will be documented with measures and photographs before and after cleansing and debridement (as needed). Clean wounds treated topically with active therapy will be covered with a non-adherent layered absorbent foam dressing with an external protective third layer. Mild compression will be applied with continued off-loading at least 2 week after closure. Follow-up evaluation after closure at 1 and 3 months. Receives: Device: Platelet Rich Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete wound closure
- An independent validation will be performed by an independent wound care specialist who will determine if the wound is fully closed, demonstrating 100% re-epithelialization persisting for two (2) subsequent weekly assessments. The validation will be reviewed with the treating researcher and the PI to formalize the results reported to the biostatistician for analysis. The biostatistician will perform and report the following analysis.
- Number of subjects achieving complete epithelialization at 12 weeks in the Intent to Treat (ITT) population.
- Number of subjects achieving complete epithelialization at 12 weeks in the Per Protocol (PP) population.
Measured: 12 weeks of active therapy weekly applications
Secondary outcomes (1)
Safety- Adverse Events, Serious Adverse Events, Deviations, Violations
The biostatistician will measure and report:
- Adverse Events (AE), including any untoward or unfavorable medical occurrence in a human study participant, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with a participant's involvement in the research, whether or not considered related to participation in the research, and
- Serious Adverse Events (SAE), including any adverse event that: i) results in death, ii) is life-threatening, or places the participant at immediate risk of death from the event as it occurred, iii) requires or prolongs hospitalization, iv) causes persistent or significant disability or incapacity,and/o v) results in congenital anomalies or birth defects vi) Is another condition which in the investigator's judge to represent significant hazards, and 3) Unanticipated Problem (UP):
Defined by DHHS 45 CFR part 46 as any incident, experience, or outcome that meets the criteria.
Measured: Screening Phase- 2 weeks and Active Treatment Phase- 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start15 Apr 2025
- Primary completion15 May 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetic Foot UlcerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- TROPOCELLS(R) Autologous Platelet-Rich Plasma (PRF) Prospective, open-label, non-randomized, single-arm, single-agent Tropocells(R) Platelet-rich fibrin (PRF) device used to render PRF therapy applied weekly, with the primary endpoint complete (100%) wound closure response to a 12-week treatment period, where closed wounds will undergo an adjudicated assessment.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Estar Medical dba Medical Technologies, LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- WCG IRB
- Responsible party
- Sponsor
- Investigators
- Adrianne P Smith, MD, Study director, Sanogenix Medical, LLCMarcus L. Gitterle, MD, Principal investigator, WoundCentrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810726
- Sponsor's protocol ID
- RND054-Tropocells PRF for DFU
- Status last verified
- Jun 2025
- First submitted
- 17 Jan 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual patient data (IPD) will be shared with the organizations used to analyze the data (Strategic Solutions, Inc) and to present the data to the FDA/CBER for the 510K Submission.
Publications
Piccin A, Di Pierro AM, Canzian L, Primerano M, Corvetta D, Negri G, Mazzoleni G, Gastl G, Steurer M, Gentilini I, Eisendle K, Fontanella F. Platelet gel: a new therapeutic tool with great potential. Blood Transfus. 2017 Jul;15(4):333-340. doi: 10.2450/2016.0038-16. Epub 2016 Jul 25.
PubMed 27483482Chen P, Vilorio NC, Dhatariya K, Jeffcoate W, Lobmann R, McIntosh C, Piaggesi A, Steinberg J, Vas P, Viswanathan V, Wu S, Game F. Guidelines on interventions to enhance healing of foot ulcers in people with diabetes (IWGDF 2023 update). Diabetes Metab Res Rev. 2024 Mar;40(3):e3644. doi: 10.1002/dmrr.3644. Epub 2023 May 25.
PubMed 37232034
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF THE SAFETY AND THE CLINICAL PERFORMANCE IN TREATMENT OF CHRONIC DIABETIC FOOT ULCER, WITH THE TROPOCELLS®, BASED AUTOLOGOUS PLATELET RICH FIBRIN (Tropocells(R) Autologous PRF Systems)
- ClinicalTrials.gov ID
- NCT06810726
- Acronym / sponsor ID
- RND054-Tropocells PRF for DFU
- Conditions
- Diabetic Foot Ulcer, Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus (T2DM), Neuroischemic Foot Ulcer, Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer), Chronic Wound Care
- Keywords
- PRF used for Wagner Grade 2 DFU, Tropocells Platelet-rich Fibrin, Platelet-rich Plasma (PRP), Platelet-derived Factors for wound care, Chronic Wound Care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Estar Medical dba Medical Technologies, LTDIndustry (pharma, biotech, devices)
- Collaborators
- WCG IRB
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 6 Feb 2025 (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 goal of this investigational study is to evaluate the safety and clinical performance of Tropocells Autologous Platelet-rich Fibrin (PRF) for wound care for both males and females, ages 18-80 years old, with Grade 1 and 2, mild to moderate, neuroischemic diabetic chronic foot ulcers in subjects with Type 1 and Type 2 Diabetes Mellitus. The main question[s] it aims to answer [is/are]:
Measure 1: Wound Closure with Tropocells Autologous PRF System for DFU Measure 2: Safety of Tropocells Autologous PRF System for DFU Researchers will enroll to acquire approximately 30 evaluable subjects with no comparison group.
Run-In Phase (2 weeks): participants with chronic diabetic foot wounds will undergo a 2-week run in phase presenting to the clinic for weekly visits, for standard of care.
Active Treatment Phase (12 weeks): participants that do not show a reduction of at least 20% may be qualified to advance to the active treatment phase where wounds will be evaluated and treated weekly in the research clinic to receive standard of care with Tropocells Autologous PRF System.
Follow-up Phase (1 month and 3 months): participants with wounds that losed during the Active Treatment Phase ( 100% wound closure with two weekly assessments demonstrating persistent closure) will be advanced to the follow-up phase to show if the wound remains closed at 1 month and 3 months.
Detailed description
Run-In Phase (2 weeks): participants with chronic diabetic foot wounds will undergo a 2-week run in phase presenting to the clinic for weekly visits, where they will receive standard of care Including-
- nutritional supplementation for 2 weeks,
- wound assessment with photos and measurements,
- wound care including cleansing and debridement,
- wound dressings,
- mild compression of the lower extremity, and
- off-loading with a removable boot.
Active Treatment Phase (12 weeks): participants that do not show a reduction of at least 20% may be qualified to advance to the active treatment phase where wounds will be evaluated and treated weekly in the research clinic. In addition to standard of care, Tropocells Autologous PRF Systems gel clot will be placed on the wound bed after cleansing and debridement prior to wound dressing and off-loading.
Data will be captured for:
Primary Outcome- Clinical Performance with complete wound closure, and Secondary Outcome(s)-
- Safety assessing adverse events (AE) and severe adverse events (SAE),
- Measures of Clinical Performance including,
- trajectory of wound area reduction
- percent (%) of area reduction,
- proportion of wound area reduction
Follow-up Phase (1 month and 3 months): participants that have 100% wound closure with two weekly assessments demonstrating persistent closure, will be advanced to the follow-up phase, where they will be assessed at 1 month and 3 months with photos and measurements to show if they remain closed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- TROPOCELLS(R) Autologous Platelet-Rich Plasma (PRF) Prospective, open-label, non-randomized, single-arm, single-agent Tropocells(R) Platelet-rich fibrin (PRF) device used to render PRF therapy applied weekly, with the primary endpoint complete (100%) wound closure response to a 12-week treatment period, where closed wounds will undergo an adjudicated assessment.
| Arm | Type | Receives |
|---|---|---|
| T1DM,T2DM participants with non-infected, neuroischemic, chronic foot ulcers | Experimental | Device: Platelet Rich PlasmaDuring Screen-the participant will be treated with standard of care (SOC) for 2 weeks, including education, nutritional supplement, weekly wound assessments and care with off-loading. After the two weekly visits, subjects who meet the inclusion/exclusion criterion, show adequate perfusion and area reduction less than 20%, and comply with the standard of care will be enrolled in the Active Treatment Phase. During the Active Treatment Phase, subjects will be treated weekly with TropoCells® Autologous Platelet-rich Fibrin (PRF) for twelve (12) weeks and continued SOC. Wound area will be documented with measures and photographs before and after cleansing and debridement (as needed). Clean wounds treated topically with active therapy will be covered with a non-adherent layered absorbent foam dressing with an external protective third layer. Mild compression will be applied with continued off-loading at least 2 week after closure. Follow-up evaluation after closure at 1 and 3 months. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Male or female ≥ 18 years of age
- Type 1 or Type 2 Diabetes
- Grade 2, DFU, non-infected, below the ankle,1.0-12.0 cm2, present ≥ 30 day
- Ulcer Size 1.0 cm2 to 12.0 cm2
- Wound location will be distal to the malleolus, excluding between the toes, with no exposed capsule, tendon, or bone, and no tunneling, undermining, or sinus tracts, a depth of ≤ 5mm
Key exclusion criteria (24 listed)
- Life expectancy is less than 12 months.
- Anemia Hgb ≤ 10 g/dL and HCT ≤ 27%.
- Ulcers of other than diabetic foot pathophysiology.
- Participation in another clinical trial involving a device or a systematically administered investigational study drug or treatment within 30 days.
- Documented sepsis, proven with blood cultures, within 2 weeks of the trial or during the Screening Phase.
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 |
|---|---|---|
| Platelet Rich PlasmaTropocells(R) Autologous Platelet-Rich Fibrin | Device | T1DM,T2DM participants with non-infected, neuroischemic, chronic foot ulcers |
Primary outcome
Complete wound closure
Time frame: 12 weeks of active therapy weekly applications
* An independent validation will be performed by an independent wound care specialist who will determine if the wound is fully closed, demonstrating 100% re-epithelialization persisting for two (2) subsequent weekly assessments. The validation will be reviewed with the treating researcher and the PI to formalize the results reported to the biostatistician for analysis. The biostatistician will perform and report the following analysis. * Number of subjects achieving complete epithelialization at 12 weeks in the Intent to Treat (ITT) population. * Number of subjects achieving complete epithelialization at 12 weeks in the Per Protocol (PP) population.
1 secondary outcome
Safety- Adverse Events, Serious Adverse Events, Deviations, Violations
Time frame: Screening Phase- 2 weeks and Active Treatment Phase- 12 weeks
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 12 Jun 2025.
- Background: PubMed 27483482Piccin A, Di Pierro AM, Canzian L, Primerano M, Corvetta D, Negri G, Mazzoleni G, Gastl G, Steurer M, Gentilini I, Eisendle K, Fontanella F. Platelet gel: a new therapeutic tool with great potential. Blood Transfus. 2017 Jul;15(4):333-340. doi: 10.2450/2016.0038-16. Epub 2016 Jul 25.
- Background: PubMed 37232034Chen P, Vilorio NC, Dhatariya K, Jeffcoate W, Lobmann R, McIntosh C, Piaggesi A, Steinberg J, Vas P, Viswanathan V, Wu S, Game F. Guidelines on interventions to enhance healing of foot ulcers in people with diabetes (IWGDF 2023 update). Diabetes Metab Res Rev. 2024 Mar;40(3):e3644. doi: 10.1002/dmrr.3644. Epub 2023 May 25.
- Individual participant dataSharing planned: Yes. Individual patient data (IPD) will be shared with the organizations used to analyze the data (Strategic Solutions, Inc) and to present the data to the FDA/CBER for the 510K Submission.
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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.
Adrianne P Smith, MD study director
Sanogenix Medical, LLC
Marcus L. Gitterle, MD principal investigator
WoundCentrics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Platelet Rich Plasma in people with Diabetic Foot Ulcer and Type 1 Diabetes Mellitus, run by Estar Medical dba Medical Technologies, LTD at 2 sites 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 23 inclusion and 24 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 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Marcus L. Gitterle, MD, FACCWS ((830) 643-6166, marcus.gitterle@woundcentrics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete wound closure (time frame: 12 weeks of active therapy weekly applications). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06810726, which also lists 2 linked publications.
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 12 Jun 2025.