What is Orion17 studying for diabetic foot ulcers?

Orion17 is being studied to see if adding it to standard wound care helps improve healing in people with diabetic foot ulcers. Researchers want to find out if this amniotic membrane allograft increases the chances of complete wound closure within 12 weeks. This study is led by Legacy Medical Consultants to explore better treatment options for diabetic foot ulcers.

Who may be eligible for this diabetic foot ulcer clinical trial?

Adults aged 50 to 85 with diabetic foot ulcers that meet specific size and location criteria may be eligible. Participants must be able to walk and under medical care for diabetes. People with certain infections, cancerous ulcers, or other serious conditions may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this diabetic foot ulcer clinical trial?

Study-related care, including the study device and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs related to attending study appointments.

Actively Recruiting

Phase Not Applicable

Age: 50Years - 85Years

All Genders

ID06420245

Clinical Utility of an Amniotic Membrane Allograft for Diabetic Foot Ulcer Wound Management A Prospective, Post-market Randomized Controlled Trial to Demonstrate Use of Orion17 in Diabetic Foot Ulcer Management

Led by Legacy Medical Consultants · Updated on 2026-06-05

240

Participants Needed

Research Sites

34 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the use of Orion17, a dual-layer amniotic membrane allograft, in addition to standard wound care for people over 50 years old with diabetic foot ulcers. The study aims to compare the healing outcomes between those receiving standard wound care alone and those receiving standard care plus the amniotic membrane allograft. The main goal is to determine the rate of complete wound closure after 12 weeks of treatment. Participants will be randomly assigned to one of two groups one receiving standard wound care, which includes surgical cleaning, infection screening, weekly collagen alginate dressings, and off-loading devices and another receiving the same standard care plus weekly applications of the Orion17 amniotic membrane allograft. The treatment period lasts 12 weeks, during which wound healing progress is closely monitored. Throughout the study, participants will visit their doctor weekly for wound assessments and to complete quality of life questionnaires. Researchers will measure outcomes such as incidence and time to complete wound closure, changes in wound size, quality of life improvements, and record any adverse events. Follow-up monitoring continues for six months after treatment to track wound recurrence and other health events, ensuring comprehensive evaluation of the treatments over time.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 50Years - 85Years

All Genders

Eligibility Criteria

You may qualify if you...

Ambulatory patients aged 50 to 85 years
Able and willing to provide informed consent and comply with study requirements
Presence of Wagner grade 1 or superficial Wagner grade 2 diabetic foot ulcer extending at least through the dermis and located below the medial ankle bone
Largest ulcer selected if multiple ulcers present, must be visible and measurable with eKare Insights
Non-study ulcers must be more than 2 cm away from the selected ulcer
Ulcer identified at least 4 weeks before screening and less than 52 weeks from informed consent
Ulcer size between 1.0 cm2 and 25 cm2 at screening and first wound management visit
Ulcer offloaded according to standard care during run-in period before randomization
Under care of a clinician for diabetes and other medical conditions
Adequate foot circulation confirmed by specific tests within 30 days of screening

You will not qualify if you...

Foot ulcer caused by a condition other than diabetes
Five or more ulcers on the target limb
Ulcer related to Charcot neuroarthropathy
Use of antibiotic impregnated dressing within 4 weeks before screening
Ulcer suspected or confirmed to be cancerous
Ulcer site previously treated with radiation therapy
Presence of venous leg ulcers
Active infection near or at ulcer site
Ulcer area reduced by 20% or more after 4-week run-in period
Active bone infection within 30 days of run-in period start
Raynaud's disease
Severe arterial ischemia preventing healing
Use of immunosuppressants or systemic corticosteroids recently or anticipated
Active cancer treatment or chemotherapy within 30 days before run-in or anticipated during study
Poor metabolic control with HbA1c 12.0% or higher
Current or recent participation in other investigational studies
Use of advanced skin substitutes on the ulcer within 60 days before run-in
Use of prohibited topical therapies or immune modulators on ulcer during study
Use of COX-2 inhibitors such as celecoxib or valdecoxib
Serum creatinine over 2.5 mg/dL within 30 days before run-in
Autoimmune connective tissue disease
End stage renal disease
Any condition compromising ability to complete study
History of poor adherence to medical therapy or clinic visits
Pregnancy or planning pregnancy during study
Life expectancy less than one year

Research Team

Cyaandi Dove, DPM

Christopher Schultz, BS, CCRA, ACRP-PM

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here