Diabetic Foot UlcerREBOUNDNCT06420245
Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management
A study testing Orion TM Amniotic Membrane Allograft in people with Diabetic Foot Ulcer, run by Legacy Medical Consultants at 8 sites in United States.
Trial summary
The goal of this clinical trial is to learn if use of Orion™, a dual-layer amniotic membrane allograft, in addition to standard wound care treatment can improve patient outcomes for people over the age of 50 with diabetic foot ulcers. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Orion TM Amniotic Membrane Allograft
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 8 sitesUnited States
- Study dates
- 30 Dec 2025to Jul 2027
- Phase
- Interventional
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulatory patients ≥ 50 and ≤ 85 years of age;
- Willing and able to provide informed consent;
- Willing and able to comply with study requirements;
- Presence of Wagner 1 and superficial Wagner 2 DFU extending at least through the dermis provided the DFU is located in the foot distal to the medial malleolus
- If multiple Wagner 1 and superficial Wagner 2 DFUs are present, the largest ulcer meeting DFU eligibility criteria will be selected as the index DFU in the study;
- Index ulcer is able to be visualized and accurately measured with eKare Insights;
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- Non-study ulcers must be > 2 cm (.79 in.) from the index ulcer;
- Index DFU identified ≥ 4 weeks prior to study screening and < 52 weeks from the date of informed consent;
- Index DFU area > 1.0 cm2 (0.39 in.) and < 25 cm2 (9.84 in.) at screening and at Wound Management Period Visit #1;
- Index DFU offloaded according to SOC for entire run-in period, prior to randomization;
- Potential participant is under the care of a clinician for diabetic management and other medical conditions (the site PI may assist/direct the patient in the pre-screening period to obtain a PCP).
- Index foot has adequate circulation defined as meeting one (1) of the following within 30 days of screening:
- ABI ≥ 0.7 and ≤ 1.3 AND TBI > 0.7; B. Dorsum transcutaneous oxygen tension measurement (TcPO2) ≥ 40 mmHg; C. Arterial duplex with biphasic flow in BOTH the DP and PT arteries verified by PI and documented.
Who cannot join
- Index foot ulcer documented to be caused by a medical condition other than diabetes;
- Potential subject has five (5) or more DFUs and/or VLUs in the target limb;
- DFU is secondary to Charcot neuroarthropathy;
- Treatment with an antibiotic impregnated primary dressing ≤ 4 weeks prior to study screening;
- Index ulcer is potentially or confirmed by biopsy to be cancerous;
- Index ulcer site has undergone radiation therapy;
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- Venous leg ulcers in diabetic patients;
- Active infection proximal to or at site of index ulcer;
- Index foot ulcer reduced in area by ≥ 20% at the end of the 4-week run-in period;
- Presence of active osteomyelitis or bone infection as verified by x-ray /MRI within 30 days of visit #1 of the run-in period;
- Raynaud's disease;
- Unreconstructible arterial ischemia which may lead to nonhealing;
- Treatment with immunosuppressants, including systemic corticosteroids for ≥ 2 weeks within 30 days prior to study screening, or are anticipated during study participation;
- Any active cancer undergoing treatment ≤ 30 days prior to wound management visit #1 of the run-in period, or is anticipated during study participation;
- Treatment with chemotherapy within 30 days of the first study wound management visit of the run-in period, or is anticipated during study participation;
- Diabetics with poor metabolic control, defined as HbA1c ≥ 12.0%, within 30 days of visit #1 of the run-in period;
- Participation in an investigational device, biologic, or drug study currently or within 30 days of study wound management visit #1 of the run-in period;
- Prior use of any advanced skin substitute product on the index ulcer within 60 days of visit #1 of the run-in period;
- Index ulcer was continued to be treated after visit #1 of the run-in period and/or anticipate treatment during study participation with any of the following prohibited therapies:
- Biomedical or topical growth factor;
- Topical steroids applied to the index ulcer surface;
- On medications that are considered immune system modulators that could affect graft incorporation;
- Scarlet red dressing;
- Dakin's solution;
- Mafenide acetate;
- Tincoban;
- Zinc sulfate;
- Povidone-iodine solution;
- Polymyxin/nystatin;
- Chlorhexidine;
- Patient is taking a cyclooxygenase-2 inhibitor (COX-2 inhibitor); such as, celecoxib (Celebrex, Consensi, Elyxyb), valdecoxib (Bextra), amlodipine (Consensi);
- Patient has serum creatinine > 2.5 mg/dL within 30 days of study wound management visit #1 of the run-in period;
- Autoimmune connective tissue disease;
- End stage renal disease (ESRD);
- Presence of any condition which would seriously compromise the subject's ability to complete this study;
- Known history of poor adherence to medical therapy and/or clinic appointments;
- Pregnant, or planning to become pregnant during the study;
- Life expectancy < 1 year.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Rosalind Franklin University of Medicine and Science
Chicago, Illinois, 60064
Stamford Health Medical Group
Darien, Connecticut, 06820
DPMG
Palm Springs, California, 92262
Chesapeake Research Group
Pasadena, Maryland, 21122
Optimum Care Research Center
Pembroke Pines, Florida, 33025
Oregon Health & Science University
Portland, Oregon, 97239
Center for Clinical Research Inc.
San Francisco, California, 94115
ILD Research Center
Vista, California, 92081
About this study
Official title: A Prospective, Post-market Randomized Controlled Trial (RCT) to Demonstrate Clinical Utility of an Amniotic Membrane Allograft in Diabetic Foot Ulcer (DFU) Wound Management
The goal of this clinical trial is to learn if use of Orion™, a dual-layer amniotic membrane allograft, in addition to standard wound care treatment can improve patient outcomes for people over the age of 50 with diabetic foot ulcers. The study aims to determine the incidence of complete wound closure at the end of 12 weeks of treatment. Researchers will compare the outcomes between a group of people treated with standard wound care and another group treated with standard wound care in addition to the amniotic membrane allograft to see if the amniotic membrane allograft improves wound healing.
During the study, participants will visit their doctor weekly over a 12 week period, which is standard for diabetic foot ulcer treatment procedures, and fill out a questionnaire measuring quality of life.
Read the detailed description
Lower extremity diabetic ulcers are a common complication affecting millions of people in the United States. The purpose of this study is to evaluate the clinical utility of Orion™, a dual-layer amniotic membrane allograft, versus standard wound care in the management of diabetic foot ulcers. Amniotic membrane allografts are confirmed by the FDA Tissue Reference Group to meet the criteria for regulation solely under Section 361 of the PHS Act as defined in 21 CFR Part 1271 for the management of diabetic foot ulcers. Investigators hypothesize that the group of participants who receive amniotic membrane allografts in addition to standard wound care will experience a faster rate and higher incidence of complete wound closure compared to standard wound care alone. For only partially healed wounds, investigators anticipate a statistically significant reduction in the size of the ulcer and improved quality of life for participants in the experimental arm compared to standard wound care alone.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Orion TM Amniotic Membrane Allograft, Standard of Care (SOC)
- Keywords
- amniotic membrane allograft, diabetic foot ulcer, DFU
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orion TM Amniotic Membrane AllograftDevice
The intervention is a sterile allograft made from dehydrated extracellular matrix, designed to promote wound healing by providing a reliable and protective wound covering. Amniotic membranes are hypothesized to promote healing in open wounds by serving as a scaffold to support native tissue ingrowth, encouraging angiogenesis, and limiting microbial spread.
Standard of Care (SOC)Procedure or surgery
Standard wound care entails surgical debridement as needed to remove all non-viable tissue, screening for infection and probing of the wound for bone, weekly application of a collagen alginate primary dressing, and off-loading using a removable diabetic offloading cam-walker or total contact cast.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SOC) | Active comparator | Standard of care DFU wound management Receives: Procedure: Standard of Care (SOC) |
| Amniotic Membrane plus Standard of Care | Experimental | Weekly application of Orion™ amniotic membrane allograft in addition to standard of care DFU wound management Receives: Device: Orion TM Amniotic Membrane Allograft; Procedure: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Complete Wound Closure
Percentage of enrolled study participants demonstrating 100% re-epithelialization of the index wound without leaking exudate at 12 weeks post-randomization.
Measured: starting from randomization until last visit of the 12-week wound management period
Secondary outcomes (13)
Time to complete wound closure
time to 100% re-epithelialization of the index ulcer without leaking exudate as assessed by Kare inSight®, starting at randomization through identification of complete wound closure.
Measured: From time of randomization until the end of the twelve (12) week Wound Management Period.
Incidence of complete wound closure
Incidence of complete wound closure, defined as 100% re-epithelialization of the index ulcer without leaking exudate as assessed by eKare inSight® at eight (8) weeks post-randomization.
Measured: From time of randomization to eight (8) weeks post-randomization.
Number of Orion™ Allografts or collagen alginate (SOC) dressings required for complete wound closure.
The number of Number of Orion™ Allografts or collagen alginate (SOC) dressings required for complete wound closure during twelve (12) week Wound Management Period.
Measured: From the time of randomization through the twelve (12) week Wound Management Period.
Change in Quality of Life metrics
Change in QoL metrics at twelve (12) weeks post-randomization compared to baseline as reported by the subject in the WOUND-Q QoL questionnaires: Life Impact (8-32; higher is better); Lower Limb Symptoms (10-40; higher is better)
Measured: starting from randomization to last visit of the 12-week wound management period
Recurrence Within Six Months
Recurrence within six (6) months post wound managment period completion, defined as meeting the primary endpoint and reopening of index ulcer at the same site within six (6) months.
Measured: starting from last visit of the 12-week wound management period until 6-month follow-up visit
Change in wound size
Percent area change of index ulcer at completion of twelve (12) weeks post-randomization.
Measured: from the time of randomization through twelve (12) weeks post-randomization.
Change in QoL metrics in follow-up.
Change in QoL metrics to six (6) months after completion of the Wound Management Period as reported by the patient in the WOUND-Q QoL questionnaire.
Measured: From time of completion of the Wound Management Period through six (6) months.
Adverse events
Adverse events from randomization through six (6) month follow-up.
Measured: From the time of randomization through six (6) month follow-up.
Serious adverse events
Occurrence of serious adverse events (SAEs) from randomization through six (6) month follow-up.
Measured: From the time of randomization through six (6) month follow-up.
Major amputations
Major amputations defined as amputation above the metatarsals.
Measured: From the time of randomization through six (6) month follow-up.
Minor amputations
Minor amputations defined as amputation involving toe or metatarsal only.
Measured: From the time of randomization through six (6) month follow-up.
Hospital admission(s)
Hospital admission(s) and diagnosis from randomization through six (6) month follow-up.
Measured: From the time of randomization through six (6) month follow-up.
Emergency Department (ED) visit(s)
ED visit(s) without admission through six (6) month follow-up.
Measured: From the time of randomization through six (6) month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start30 Dec 2025
- Primary completionNov 2026 (estimated)
- Study completionJul 2027 (estimated)
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Legacy Medical Consultants
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420245
- Sponsor's protocol ID
- LEGA-CLIN-2024-01
- Acronym
- REBOUND
- Status last verified
- Jun 2026
- First submitted
- 14 May 2024
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Post-market Randomized Controlled Trial (RCT) to Demonstrate Clinical Utility of an Amniotic Membrane Allograft in Diabetic Foot Ulcer (DFU) Wound Management
- ClinicalTrials.gov ID
- NCT06420245
- Acronym / sponsor ID
- REBOUND / LEGA-CLIN-2024-01
- Conditions
- Diabetic Foot Ulcer
- Keywords
- amniotic membrane allograft, diabetic foot ulcer, DFU
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Legacy Medical ConsultantsIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2025 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 17 May 2024 (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 clinical trial is to learn if use of Orion™, a dual-layer amniotic membrane allograft, in addition to standard wound care treatment can improve patient outcomes for people over the age of 50 with diabetic foot ulcers. The study aims to determine the incidence of complete wound closure at the end of 12 weeks of treatment. Researchers will compare the outcomes between a group of people treated with standard wound care and another group treated with standard wound care in addition to the amniotic membrane allograft to see if the amniotic membrane allograft improves wound healing.
During the study, participants will visit their doctor weekly over a 12 week period, which is standard for diabetic foot ulcer treatment procedures, and fill out a questionnaire measuring quality of life.
Detailed description
Lower extremity diabetic ulcers are a common complication affecting millions of people in the United States. The purpose of this study is to evaluate the clinical utility of Orion™, a dual-layer amniotic membrane allograft, versus standard wound care in the management of diabetic foot ulcers. Amniotic membrane allografts are confirmed by the FDA Tissue Reference Group to meet the criteria for regulation solely under Section 361 of the PHS Act as defined in 21 CFR Part 1271 for the management of diabetic foot ulcers. Investigators hypothesize that the group of participants who receive amniotic membrane allografts in addition to standard wound care will experience a faster rate and higher incidence of complete wound closure compared to standard wound care alone. For only partially healed wounds, investigators anticipate a statistically significant reduction in the size of the ulcer and improved quality of life for participants in the experimental arm compared to standard wound care alone.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC) | Active comparator | Procedure: Standard of Care (SOC)Standard of care DFU wound management |
| Amniotic Membrane plus Standard of Care | Experimental | Device: Orion TM Amniotic Membrane Allograft, Procedure: Standard of Care (SOC)Weekly application of Orion™ amniotic membrane allograft in addition to standard of care DFU wound management |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Ambulatory patients ≥ 50 and ≤ 85 years of age;
- Willing and able to provide informed consent;
- Willing and able to comply with study requirements;
- Presence of Wagner 1 and superficial Wagner 2 DFU extending at least through the dermis provided the DFU is located in the foot distal to the medial malleolus
- If multiple Wagner 1 and superficial Wagner 2 DFUs are present, the largest ulcer meeting DFU eligibility criteria will be selected as the index DFU in the study;
Key exclusion criteria (38 listed)
- Index foot ulcer documented to be caused by a medical condition other than diabetes;
- Potential subject has five (5) or more DFUs and/or VLUs in the target limb;
- DFU is secondary to Charcot neuroarthropathy;
- Treatment with an antibiotic impregnated primary dressing ≤ 4 weeks prior to study screening;
- Index ulcer is potentially or confirmed by biopsy to be cancerous;
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 |
|---|---|---|
| Orion TM Amniotic Membrane AllograftThe intervention is a sterile allograft made from dehydrated extracellular matrix, designed to promote wound healing by providing a reliable and protective wound covering. Amniotic membranes are hypothesized to promote healing in open wounds by serving as a scaffold to support native tissue ingrowth, encouraging angiogenesis, and limiting microbial spread. | Device | Amniotic Membrane plus Standard of Care |
| Standard of Care (SOC)Standard wound care entails surgical debridement as needed to remove all non-viable tissue, screening for infection and probing of the wound for bone, weekly application of a collagen alginate primary dressing, and off-loading using a removable diabetic offloading cam-walker or total contact cast. | Procedure or surgery | Amniotic Membrane plus Standard of Care, Standard of Care (SOC) |
Primary outcome
Incidence of Complete Wound Closure
Time frame: starting from randomization until last visit of the 12-week wound management period
Percentage of enrolled study participants demonstrating 100% re-epithelialization of the index wound without leaking exudate at 12 weeks post-randomization.
13 secondary outcomes
Time to complete wound closure
Time frame: From time of randomization until the end of the twelve (12) week Wound Management Period.
Incidence of complete wound closure
Time frame: From time of randomization to eight (8) weeks post-randomization.
Number of Orion™ Allografts or collagen alginate (SOC) dressings required for complete wound closure.
Time frame: From the time of randomization through the twelve (12) week Wound Management Period.
Change in Quality of Life metrics
Time frame: starting from randomization to last visit of the 12-week wound management period
Recurrence Within Six Months
Time frame: starting from last visit of the 12-week wound management period until 6-month follow-up visit
Change in wound size
Time frame: from the time of randomization through twelve (12) weeks post-randomization.
Change in QoL metrics in follow-up.
Time frame: From time of completion of the Wound Management Period through six (6) months.
Adverse events
Time frame: From the time of randomization through six (6) month follow-up.
Serious adverse events
Time frame: From the time of randomization through six (6) month follow-up.
Major amputations
Time frame: From the time of randomization through six (6) month follow-up.
Minor amputations
Time frame: From the time of randomization through six (6) month follow-up.
Hospital admission(s)
Time frame: From the time of randomization through six (6) month follow-up.
Emergency Department (ED) visit(s)
Time frame: From the time of randomization through six (6) month follow-up.
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 28 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orion TM Amniotic Membrane Allograft in people with Diabetic Foot Ulcer, run by Legacy Medical Consultants 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 13 inclusion and 38 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: under way, not looking for participants, as of the sponsor's last update on 28 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.
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?
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?
Incidence of Complete Wound Closure (time frame: starting from randomization until last visit of the 12-week wound management period). 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 28 Aug 2026.