Evaluating a new collagen treatment for diabetic foot ulcers

A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Assessing the Efficacy of a Purified Native Type 1 Collagen Extracellular Matrix With Polyhexamethylene Biguanide Antimicrobial (PCMP) and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers

This study is testing a new collagen treatment for diabetic foot ulcers to see if it helps heal wounds better than standard care alone.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 170 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Organogenesis (industry)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Clevland, Ohio)
• Trial ID: NCT06618612 on ClinicalTrials.gov

What this trial studies

This clinical trial is designed to assess the effectiveness of a purified native type 1 collagen extracellular matrix combined with an antimicrobial agent, compared to standard care alone, in treating chronic diabetic foot ulcers. The study will involve at least 170 participants who will be randomly assigned to receive either standard care, the new collagen treatment with standard care, or another variant of the collagen treatment with standard care. Participants will be monitored weekly for up to 12 weeks to evaluate healing progress, with follow-up visits to confirm complete wound closure.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with type 1 or 2 diabetes and chronic foot ulcers that meet specific size and duration criteria.

Not a fit: Patients with ulcers not meeting the study criteria or those with severe complications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve healing rates for patients with chronic diabetic foot ulcers.

How similar studies have performed: Previous studies have shown promise in using collagen-based treatments for wound healing, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. At least 18 years of age or older.
2. Diagnosis of type 1 or 2 Diabetes mellitus.
3. At enrollment, target ulcer with a minimum surface area of 1.0 cm2
4. The target ulcer must have been present for a minimum of 4 weeks
5. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
6. The target ulcer must be Wagner 1 or 2 grade
7. The affected limb must have adequate perfusion confirmed by vascular assessment.
8. If the potential subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.
9. Target ulcers located on the plantar aspect of the foot must be offloaded for at least 14 days prior to enrollment.
10. The potential subject must consent to using the prescribed offloading method for the duration of the study.
11. The potential subject must agree to attend the weekly study visits required by the protocol.
12. The potential subject must be willing and able to participate in the informed consent process.

Exclusion Criteria:

1. The potential subject is known to have a life expectancy of \< 6 months.
2. The potential subject's target ulcer is not secondary to diabetes.
3. The target ulcer is infected or there is cellulitis in the surrounding skin.
4. The target ulcer exposes tendon or bone.
5. There is evidence of osteomyelitis
6. There is an infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.
7. The potential subject is receiving immunosuppressants or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing.
8. The potential subject is taking hydroxyurea.
9. The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.
10. The potential subject with a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.
11. The potential subject has a controlled glycated hemoglobin (HbA1c) within 3 months of the initial screening visit.
12. The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.
13. Women who are pregnant or considering becoming pregnant within the next 6 months.
14. The potential subject has end stage renal disease requiring dialysis.
15. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.
16. A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
17. The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.
18. The potential subject has a malnutrition indicator score \<17 as measured on the Mini Nutritional Assessment.

Where this trial is running

Clevland, Ohio

• Kent State University, College of Podiatric Medicine — Clevland, Ohio, United States (RECRUITING)

Study contacts

• Study coordinator: Brett Madden

Conditions: Diabetic Foot Ulcer, DFU, Chronic Diabetic Foot Ulcer, Non-healing DFU