Diabetic Foot UlcerPhase 4ELITENCT07014176
Nonhealing Diabetic Foot Ulcers Treated With Standard of Care (SOC) Alone or Standard of Care and Amnion-Intermediate-Chorion (AIC)
A Phase 4 study testing Amnion-Intermediate-Chorion in people with Diabetic Foot Ulcer, run by Cellution Biologics at 8 sites in United States.
Trial summary
The purpose of this study is to determine how well our dHPT (Dehydrated Human Placental Tissue) Product and Standard of Care work when compared to Standard of Care alone in achieving complete closure of diabetic foot. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Amnion-Intermediate-Chorion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 8 sitesUnited States
- Study dates
- 3 Jul 2025to 22 Jul 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Subjects will be eligible to participate in the study if the following conditions exist:
- 18 years of age or older.
- Diagnosis of type 1 or 2 Diabetes mellitus.
- Hemoglobin A1c (HbA1c) level is < 12% (108 mmol/mol).
- Target ulcer with a surface area at randomization of 0.7 cm2 to 20.0 cm2 measured post debridement.
- Target ulcer present for minimum of 4 weeks prior to screening visit.
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- Target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
- Target ulcer must be Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus. The ulcer may not include exposed tendon or bone.
- Affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the screening visit are acceptable:
- ABI ≥ 0.7 and ≤ 1.3;
- TBI ≥ 0.6;
- TCOM ≥ 40 mmHg;
- PVR: biphasic or triphasic.
- Subject with two or more ulcers must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
- Subject must consent to using the prescribed off-loading method for the duration of the study.
- Subject must agree to attend study visits required by the protocol.
- Subject must be willing and able to participate in the informed consent process.
Who cannot join
- Subjects will be excluded from participation in the study if any of the following conditions exist:
- Known life expectancy of < 6 months.
- Target ulcer is not secondary to diabetes.
- Target ulcer is infected or there is cellulitis in the surrounding skin.
- Evidence of osteomyelitis complicating the target ulcer.
- Infection in the target ulcer or a location that requires systemic antibiotic therapy.
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- Receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
- Topical application of steroids to the ulcer surface within one month of screening.
- Previous partial amputation on the affected foot if the resulting deformity impedes proper offloading of the target ulcer.
- Surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to screening visit ("historical" run-in period). Photographic planimetry is not required for measurements taken during the historical run-in period (e.g. calculating surface area using length x width is acceptable).
- Mini Nutritional Assessment (MNA) score of less than 17.
- Acute Charcot foot or an inactive Charcot foot that impedes proper offloading of the target ulcer.
- Women of childbearing potential (WOCBP) who are pregnant, considering becoming pregnant within the next 4 months, or are unwilling to use an appropriate form of contraception.
- Currently require dialysis or planning to start dialysis.
- Medical or psychological condition that, in the opinion of the investigator, may interfere with study assessments.
- Treated with hyperbaric oxygen therapy or a dehydrated human placental tissue (dHTP) in the 30 days prior to screening visit.
- Known sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics.
- Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
008
Allentown, Pennsylvania, 18104
003
Chicago, Illinois, 60611
006
Hilton Head Island, South Carolina, 29926
001
Jacksonville, Florida, 32216
007
Mooresville, North Carolina, 28117
004
Philadelphia, Pennsylvania, 19146
002
Rocky Mount, North Carolina, 27804
005
Santa Rosa, California, 95403
About this study
Official title: A Multicenter, Randomized Trial Evaluating Dehydrated Human Placenta Tissue (dHPT) and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot Ulcers
The purpose of this study is to determine how well our dHPT (Dehydrated Human Placental Tissue) Product and Standard of Care work when compared to Standard of Care alone in achieving complete closure of diabetic foot.
Read the detailed description
Chronic wounds affect a significant percentage of patients over their lifetime. For example, diabetic foot ulcers (DFU) are a major health complication that affect up to 15% of individuals with diabetes mellitus over their lifetime. The treatment of chronic wounds is extremely challenging as ulcers such as DFUs may not respond to standard of care (SOC) treatment and frequently become infected.
Advanced wound products like Dehydrated Human Placental Tissue (dHPTs) have become an important strategy in the treatment of these chronic wounds by trapping and binding the patients' own cells to rebuild the dermis layer of the skin to aid in healing.
This study will evaluate the clinical utility of Amnion-Intermediate-Chorion (AIC) in the closure of diabetic foot ulcers in subjects in comparison to Standard of Care treatment.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Amnion-Intermediate-Chorion, Standard of Care (SOC)
- Keywords
- DFU, Diabetic Ulcer, Foot Wound, Diabetic Foot Ulcer, Placenta
- Medical subject headings
- Diabetic Foot, Foot Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amnion-Intermediate-ChorionOther
Dehydrated human placental multilayer allograft from derived donated human tissue. AIC contains amnion and chorion layers as well as basement membrane and trophoblast.
Standard of Care (SOC)Procedure or surgery
Standard of care is to establish a clean, healthy wound bed and optimize the wound environment to have the best chance of healing the wound. This is achieved through wound cleansing, debridement, offloading and moisture balance.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first. Receives: Procedure: Standard of Care (SOC) |
| AIC and Standard of Care | Experimental | Participants with a diabetic foot ulcer (DFU) will receive treatment with an Amnion-Intermediate-Chorion (AIC) sheet product, a dehydrated multilayer human placental tissue derived from donated human tissue, and weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first. Receives: Other: Amnion-Intermediate-Chorion; Procedure: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of ulcers with complete wound closure
The percentage of DFU target ulcers achieving complete wound closure. Closure is defined as 100% re-epithelialization of the ulcer surface without detectable exudate.
Measured: 1-12 weeks
Secondary outcomes (5)
Time to complete closure for ulcer
Time to closure will be determined for the treatment group and compared to Standard of Care. Closure is defined by 100% re-epithelialization of the ulcer surface without detectable exudate.
Measured: 1-12 weeks
Percentage of wound area change for target ulcer
Percentage wound area changes from week 1 to week 12 will be calculated weekly from measurements with digital photographic images and physical examination.
Measured: 1-12 weeks
Changes to pain associated with the target ulcer
Change in pain in the target ulcer assessed using the Visual Analog Scale (VAS) from week 1 to week 12. VAS is a tool that uses a 0-10 (no to extreme pain) point scale to measure pain intensity.
Measured: 1-12 weeks
Incidence of Adverse events
The incidence of adverse events will be evaluated weekly from the first study visit to wound healing and/or final visit.
Measured: 1-12 weeks
Determine changes in Quality of Life
Changes in quality of life using both the Wound Quality of Life (wQOL) and Forgotten Wound Score (FWS) questionnaires that measure the health-related quality of life (HRQoL) of patients with chronic wounds. wQOL questionnaire is scored using a 5-point Likert scale, where 0 means "not at all" and 4 means "very much". Higher scores indicate greater impairment of quality of life. Higher the score indicates lower quality of life. [Time Frame: Visits 2, 5, 9, and 12/Final Visit]. FWS questionnaire measures 12 activities scored 0-4. Responses are summed and divided by the number of completed items. The mean value is then multiplied by 25 to obtain the total score of 0-100. Higher the score indicates lower quality of life. [Time Frame: Visits 2, 5, 9, and 12/Final Visit].
Measured: 1-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start3 Jul 2025
- Primary completion15 Jun 2026
- Study completion22 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cellution Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Research Director, Study director, Cellution Biologics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014176
- Sponsor's protocol ID
- CELLBIO-2025-001
- Acronym
- ELITE
- Status last verified
- Aug 2026
- First submitted
- 1 Jun 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Trial Evaluating Dehydrated Human Placenta Tissue (dHPT) and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT07014176
- Acronym / sponsor ID
- ELITE / CELLBIO-2025-001
- Conditions
- Diabetic Foot Ulcer
- Keywords
- DFU, Diabetic Ulcer, Foot Wound, Diabetic Foot Ulcer, Placenta
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Cellution BiologicsIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2025 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 22 Jul 2026 (actual)
- First posted
- 10 Jun 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 purpose of this study is to determine how well our dHPT (Dehydrated Human Placental Tissue) Product and Standard of Care work when compared to Standard of Care alone in achieving complete closure of diabetic foot.
Detailed description
Chronic wounds affect a significant percentage of patients over their lifetime. For example, diabetic foot ulcers (DFU) are a major health complication that affect up to 15% of individuals with diabetes mellitus over their lifetime. The treatment of chronic wounds is extremely challenging as ulcers such as DFUs may not respond to standard of care (SOC) treatment and frequently become infected.
Advanced wound products like Dehydrated Human Placental Tissue (dHPTs) have become an important strategy in the treatment of these chronic wounds by trapping and binding the patients' own cells to rebuild the dermis layer of the skin to aid in healing.
This study will evaluate the clinical utility of Amnion-Intermediate-Chorion (AIC) in the closure of diabetic foot ulcers in subjects in comparison to Standard of Care treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Active comparator | Procedure: Standard of Care (SOC)Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first. |
| AIC and Standard of Care | Experimental | Other: Amnion-Intermediate-Chorion, Procedure: Standard of Care (SOC)Participants with a diabetic foot ulcer (DFU) will receive treatment with an Amnion-Intermediate-Chorion (AIC) sheet product, a dehydrated multilayer human placental tissue derived from donated human tissue, and weekly treatment with standard of care (cleaning, debridement, ulcer moisture balance, and offloading) until ulcer closure, or a maximum of 12 weeks, whichever occurs first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 18 years of age or older.
- Diagnosis of type 1 or 2 Diabetes mellitus.
- Hemoglobin A1c (HbA1c) level is < 12% (108 mmol/mol).
- Target ulcer with a surface area at randomization of 0.7 cm2 to 20.0 cm2 measured post debridement.
- Target ulcer present for minimum of 4 weeks prior to screening visit.
Key exclusion criteria (18 listed)
- Subjects will be excluded from participation in the study if any of the following conditions exist:
- Known life expectancy of < 6 months.
- Target ulcer is not secondary to diabetes.
- Target ulcer is infected or there is cellulitis in the surrounding skin.
- Evidence of osteomyelitis complicating the target ulcer.
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 |
|---|---|---|
| Amnion-Intermediate-ChorionDehydrated human placental multilayer allograft from derived donated human tissue. AIC contains amnion and chorion layers as well as basement membrane and trophoblast. | Other | AIC and Standard of Care |
| Standard of Care (SOC)Standard of care is to establish a clean, healthy wound bed and optimize the wound environment to have the best chance of healing the wound. This is achieved through wound cleansing, debridement, offloading and moisture balance. | Procedure or surgery | AIC and Standard of Care, Standard of Care |
Primary outcome
Percentage of ulcers with complete wound closure
Time frame: 1-12 weeks
The percentage of DFU target ulcers achieving complete wound closure. Closure is defined as 100% re-epithelialization of the ulcer surface without detectable exudate.
5 secondary outcomes
Time to complete closure for ulcer
Time frame: 1-12 weeks
Percentage of wound area change for target ulcer
Time frame: 1-12 weeks
Changes to pain associated with the target ulcer
Time frame: 1-12 weeks
Incidence of Adverse events
Time frame: 1-12 weeks
Determine changes in Quality of Life
Time frame: 1-12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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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. This study is not recruiting at the moment.
Research Director study director
Cellution Biologics
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Amnion-Intermediate-Chorion in people with Diabetic Foot Ulcer, run by Cellution Biologics at 8 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 17 inclusion and 18 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: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of ulcers with complete wound closure (time frame: 1-12 weeks). 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 20 Aug 2026.