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

NCT06420245 | Recruiting DMC FDA Device

• 1 other identifier: LEGA-CLIN-2024-01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Diabetic Foot Ulcer

Keywords

amniotic membrane allograft; diabetic foot ulcer; DFU

Outcome Measures

Primary Outcomes (1)

• 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.

  starting from randomization until last visit of the 12-week wound management period

Secondary Outcomes (13)

• Time to complete wound closure

  From time of randomization until the end of the twelve (12) week Wound Management Period.

• Incidence of complete wound closure

  From time of randomization to eight (8) weeks post-randomization.

• Number of Orion™ Allografts or collagen alginate (SOC) dressings required for complete wound closure.

  From the time of randomization through the twelve (12) week Wound Management Period.

• Change in Quality of Life metrics

  starting from randomization to last visit of the 12-week wound management period

• Recurrence Within Six Months

  starting from last visit of the 12-week wound management period until 6-month follow-up visit

Other Outcomes (2)

• Per-Patient Product Cost

  starting from randomization until last visit of the 12-week wound management period.

• Number of wound management products used.

  Following completion of the 12-week Wound Management Period (WMP Visit #13) through the six (6) month follow-up.

Study Arms (2)

Standard of Care (SOC)

ACTIVE COMPARATOR

Standard of care DFU wound management

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

Device: Orion TM Amniotic Membrane Allograft; Procedure: Standard of Care (SOC)

Interventions

Orion TM Amniotic Membrane Allograft DEVICE

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.

Amniotic Membrane plus Standard of Care

Standard of Care (SOC) PROCEDURE

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.

Amniotic Membrane plus Standard of Care; Standard of Care (SOC)

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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:
• A. 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Legacy Medical Consultants: lead

Study Sites (2)

Center for Clinical Research Inc.

San Francisco, California, 94115, United States

RECRUITING

ILD Research Center

Vista, California, 92081, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Cyaandi Dove, DPM

CONTACT

210-567-5135; dovec@ohsu.edu

Christopher Schultz, BS, CCRA, ACRP-PM

CONTACT

719-400-7463; cschultz@ecr-inc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 17, 2024
• Study Start: December 30, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 2, 2026

Record last verified: 2025-12

Locations

US (2)