Evaluating new treatments for hard-to-heal diabetic foot ulcers

A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Assessing the Efficacy of Multiple Human Placental-Based Skin Substitutes and Standard of Care Versus SOC Alone in the Treatment of Hard-to-Heal Diabetic Foot Ulcers

This study is testing if new treatments using special placental products can help heal tough diabetic foot ulcers better than the usual care alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 272 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: StimLabs (Industry-sponsored)
• Drugs / interventions: chemotherapy, prednisone
• Locations: 5 sites (Omaha, Nebraska and 4 other locations)
• Trial ID: NCT06449638 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the effectiveness of four different dehydrated complete human placental membrane products, known as Cellular, Acellular, Matrix-like Products (CAMPs), in combination with standard of care (SOC) compared to SOC alone for treating hard-to-heal diabetic foot ulcers. The study employs a modified platform trial design, allowing for the simultaneous evaluation of multiple treatments within a single framework. Participants will be monitored over a 12-week period to determine the rate of complete ulcer closure. The trial is multicenter and randomized, ensuring a diverse patient population and robust data collection.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with type 1 or type 2 diabetes and specific criteria related to their diabetic foot ulcers.

Not a fit: Patients with diabetic foot ulcers that do not meet the specified size, duration, or location criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could provide new effective treatment options for patients suffering from hard-to-heal diabetic foot ulcers.

How similar studies have performed: Previous studies have shown promise in using cellular and tissue-based products for wound healing, indicating 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 and a maximum surface area of 25.0 cm2 measured post debridement with the MolecuLight® Imaging Device.
4. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care, prior to the initial screening visit.
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 full thickness without exposed bone.
7. The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:

   1. Ankle-Brachial Index (ABI) between 0.7 and ≤ 1.3;
   2. Toe-Brachial Index (TBI) ≥ 0.6;
   3. Transcutaneous Oxygen Measurement (TCOM) ≥ 40 mmHg;
   4. Pulse Volume Resistance (PVR): biphasic.
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 complicating the target ulcer.
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 (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).
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 glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.
12. The surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit ("historical" run-in period). MolecuLight Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).
13. The surface area measurement of the Target ulcer decreases by 20% or more during the 2-week screening phase: the 2 weeks from the initial screening visit (S1) to the TV-1 visit during which time the potential subject received SOC.
14. The potential subject has an acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.
15. Women who are pregnant or considering becoming pregnant within the next 6 months are excluded.
16. The potential subject has end stage renal disease requiring dialysis.
17. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.
18. A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.
19. The target ulcer 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.
20. The potential subject has a malnutrition indicator score \<17 as measured on the Mini Nutrition Assessment.

Where this trial is running

Omaha, Nebraska and 4 other locations

• SerenaGroup Omaha Research Center — Omaha, Nebraska, United States (Recruiting)
• Wound Care of Tulsa — Tulsa, Oklahoma, United States (Recruiting)
• SerenaGroup Research South — Jefferson Hills, Pennsylvania, United States (Not_yet_recruiting)
• Armstrong County Memorial Hospital — Kittanning, Pennsylvania, United States (Not_yet_recruiting)
• SerenaGroup Monroeville — Monroeville, Pennsylvania, United States (Recruiting)

Study contacts

• Study coordinator: Kristy Breisinger

Conditions Diabetic Foot Ulcer; Ulcer Foot; Diabetic Foot; Foot Ulcer; Cellular, Acellular, Matrix-like Product; Cellular and/or Tissue Product; Dehydrated Complete Human Placental Membrane