Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management

Diabetic Foot Ulcer Clinical Trial

— REBOUND  

Official title:

A Prospective, Post-market Randomized Controlled Trial (RCT) to Demonstrate the Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer (DFU) Wound Management

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06420245
• Other study ID #: LEGACYMED-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: July 2025

Study information

• Verified date: May 2024
• Source: Legacy Medical Consultants
• Contact: Jennifer Linksy
• Phone: 813-600-9290
• Email: jennifer[@]legacymedicalconsultants.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to learn if use of Orion TM, 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 main question it aims to answer is 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 patient outcomes.

Participants will visit their doctor weekly over a 12 week period, as per standard diabetic foot ulcer treatment procedures, and fill out a questionnaire measuring quality of life.

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 TM, 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: July 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. Subject age is between 50-80 years old

2. Presence of Wagner 1 DFU extending at least through the dermis provided it was below the aspect of the medial malleolus, and if multiple Wagner 1 DFUs present, then the largest ulcer was evaluated as the index ulcer in the study with other ulcers being more than 2 cm from the index

3. Index ulcer duration =4 weeks prior to the study screening but <52 weeks as of the date of consent

4. Index ulcer area >1.0 cm2 and <25 cm2 at screening visit and first treatment visits

5. Index ulcer offloaded for =14 days prior to randomization

6. Affected foot had adequate circulation (defined as a dorsal transcutaneous oximetry measurement (TCOM) or a skin perfusion pressure measurement of =30 mmHg, OR an ankle brachial index (ABI) of =0.7 and =1.3 within 3 months of screening, OR arterial Doppler with a minimum of biphasic flow in the dorsalis pedis and posterior tibial vessels at the level of the ankle, OR a toe brachial index (TBI) of >0.6)

7. Women of childbearing potential complied with contraception use and pregnancy tests for the study duration

8. Demonstration of understanding and willingness to participate in the study, ability to comply with the weekly visits and follow-up, and provided written informed consent.

9. Meets screening criteria 30 days following first run-in visit.

Exclusion Criteria:

1. Index ulcer deemed to be caused by a medical condition other than diabetes

2. Index ulcer is potentially or confirmed by biopsy to be cancerous

3. Subject is afflicted with Raynaud's disease

4. Arterial ischemia is a potential cause of foot ulcerations

5. Presence of active osteomyelitis or bone infection as verified by x-ray within 30 days prior to randomization

6. An infected foot ulcer on the index foot requiring use of antibiotics;

7. Subject exhibits poor metabolic control (HbA1c = 12.0) within 90 days of randomization

8. Participation in an investigational device or drug study currently or within 30 days of screening

9. More than 2 weeks of treatment with immunosuppressants, including systemic corticosteroids and/or topical steroids applied to the index ulcer surface within 1 month prior to screening, or are anticipated during study participation;

10. Treated with cytotoxic chemotherapy within one month prior to screening, or is anticipated during study participation

11. Index ulcer site has undergone radiation therapy

12. Presence of any condition which would seriously compromise the subject's ability to complete this study

13. Known history of poor adherence to medical therapy and/or clinic appointments

14. Subject is taking a selective COX-2 inhibitor

15. Subject has serum creatinine > 3.0 mg/dL within 120 days of randomization

16. Subject is non-ambulatory

17. Failure to meet screening criteria within 30 days of first run-in visit, including index ulcer reduced in area by 20% or more after 28 days of SOC during the run-in period.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Device:
• Orion TM Amniotic Membrane Allograft
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.

Procedure:
• Standard of Care (SOC)
Standard wound care entails surgical debridement to remove all necrotic tissue, screening for infection and probing of the wound for bone, application of a collagen alginate primary dressing, and off-loading using a removable diabetic offloading cam-walker.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Legacy Medical Consultants

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks after randomization into study arm following a 4-week run-in period