SDRM® vs. Collagen for Diabetic Foot Ulcers

NCT05883098 | Completed FDA Device

• 1 other identifier: PMI-SUPRASDRM®-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Supra SDRM® is FDA-cleared as a dressing for treating partial and full-thickness wounds. It is a dermal substitute that provides a barrier and an ECM-like structure to help accelerate wound healing. SUPRA SDRM® has 510k approval for partial and full-thickness wounds and has shown promising results in preliminary animal studies. The purpose of this clinical evaluation is to collect and compare outcomes data from patients with UT 1A diabetic foot ulcers treated with a commercially available dermal substitute, Supra SDRM®, as compared to an advanced standard of care (Fibracol Plus). Patient outcomes, including time to heal, healing by 12 weeks, direct costs, and infection rate, will be compared at the end of the study.

Conditions

Diabetic Foot; Ulcer Foot; Wound Heal

Keywords

Diabetic foot ucer; Wound closure matrix; Wound healing; Chronic wound

Outcome Measures

Primary Outcomes (2)

• Time to heal

  Number of weeks required to achieve 100% epithelization of the wound

  Up to 30 weeks

• Healing by 12 weeks

  Proportion of patients achieving 100% epithelization on or before week 12

  12 weeks

Secondary Outcomes (2)

• Direct costs

  Up to 30 weeks

• Infection rate

  Up to 30 weeks

Study Arms (2)

SUPRA SDRM

EXPERIMENTAL

The subject will receive wound standard of care that will include Supra SDRM as an active synthetic wound closure matrix, covered with a non-adherent dressing plus an appropriate outer dressing to maintain moisture balance, then wrapped with stretch gauze and self-adherent wrap. Supra SDRM will be applied weekly, and the exterior dressings will be redressed as necessary. Supra SDRM is FDA-cleared (K090160, K170213) for the management of partial and full-thickness wounds, such as pressure sores, leg ulcers, diabetic ulcers, and surgical wounds. It is commercialized as a single dermal substitute matrix for wound management. No preparation of SUPRA SDRM matrix is necessary. When applied to the wound SUPRA SDRM adheres well to the wound bed without the need for direct fixation. SUPRA SDRM becomes translucent after the application allowing healthcare professionals to easily assess the wound healing. SUPRA SDRM® is available in multiple sizes and can be trimmed to meet the patient's needs.

Procedure: Wound debridement; Device: Wound closure matrix application

Fibracol Plus

ACTIVE COMPARATOR

The subject will receive wound standard of care that will include Fibracol Plus collagen dressing as an active synthetic wound closure matrix, covered with a non-adherent dressing plus an appropriate outer dressing to maintain moisture balance, then wrapped with stretch gauze and self-adherent wrap. Fibracol Plus collagen dressing will be applied weekly, and the exterior dressings will be redressed as necessary. FIBRACOL™ Plus Collagen Wound Dressing with Alginate dressing contains more than just pure collagen. It's a soft, absorbent, and conformable wound dressing, composed of 90% collagen and 10% calcium alginate. In the presence of wound fluid, FIBRACOL™ Plus Dressing helps maintain a physiologically moist microenvironment at the wound surface. This environment supports granulation tissue formation, epithelialization and rapid wound healing.

Procedure: Wound debridement; Device: Wound closure matrix application

Interventions

Wound debridement PROCEDURE

The study's wounds will be mechanically debrided before the experimental or active comparator devices are applied. Debridation will be performed by a trained clinician using a curette. Necrotic tissue and slough will be removed during this procedure.

Fibracol Plus; SUPRA SDRM

Wound closure matrix application DEVICE

After wound debridement, the patients will receive the application of a wound closure matrix as dictated by their randomization allocation.

Fibracol Plus; SUPRA SDRM

Eligibility Criteria

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

You may qualify if:

• Males and females aged 18 or older.
• Subject is willing to sign an informed consent and participate in all procedures and follow-up evaluations.
• Study ulcer is diabetic in origin, located on foot or below the malleolus (UT Grade 1A).
• Study ulcer size is a minimum of 2 cm2 and a maximum of 25 cm2.
• Study ulcer has been present for a minimum of 4 weeks before enrollment and less than 1 year old.
• Study ulcer has been offloaded for at least 14 days before randomization.
• Subject does not exhibit clinical signs or symptoms of infection.
• Subject has adequate control of diabetes demonstrated by Hemoglobin A1c \< 12% within 90 days of screening.
• Subject has adequate circulation to the affected extremity.

You may not qualify if:

• Study ulcer has \> 40% wound healing during the 14 days screening period.
• Subject has a known history of poor compliance with medical treatments.
• Subject is presently participating in another clinical trial.
• Subject has a known or suspected local or systemic malignancy.
• Subject has been diagnosed with autoimmune connective tissues diseases.
• Subject has received graft material or topical growth factors on the study ulcer within the previous 30 days.
• Subject has received application of topical steroids on the study ulcer surface within the previous 30 days.
• Subject is pregnant or breast feeding.
• Subject is on dialysis.
• Subject is taking medications that are considered immune system modulators or cytotoxic chemotherapies.
• Subject cannot be on systemic antibiotics prior to randomization, however, during the treatment phase infection management may include systemic antibiotics if in conjunction with debridement.
• Subject has a known allergy to ingredients/components of Supra SDRM®.
• Subject has osteomyelitis, and/or bony prominences present in the wound.
• Subject has ulcer probing to bone and tendon. (UT Grade II or III A-D).
• Subject is unable to comply with planned study procedures and treatments.

Sponsors & Collaborators

• Polymedics Innovations Inc.: lead
• McGill University: collaborator

Study Sites (1)

WAFL Inc

Circleville, Ohio, 43113, United States

Location

Related Publications (3)

• Frykberg RG, Banks J. Challenges in the Treatment of Chronic Wounds. Adv Wound Care (New Rochelle). 2015 Sep 1;4(9):560-582. doi: 10.1089/wound.2015.0635.

  PMID: 26339534 BACKGROUND

• Mirhaj M, Labbaf S, Tavakoli M, Seifalian AM. Emerging treatment strategies in wound care. Int Wound J. 2022 Nov;19(7):1934-1954. doi: 10.1111/iwj.13786. Epub 2022 Mar 17.

  PMID: 35297170 BACKGROUND

• Haller HL, Sander F, Popp D, Rapp M, Hartmann B, Demircan M, Nischwitz SP, Kamolz LP. Oxygen, pH, Lactate, and Metabolism-How Old Knowledge and New Insights Might Be Combined for New Wound Treatment. Medicina (Kaunas). 2021 Nov 1;57(11):1190. doi: 10.3390/medicina57111190.

  PMID: 34833408 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot; Foot Ulcer

Condition Hierarchy (Ancestors)

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

Study Officials

• Jose L Ramirez Garcia Luna, MD, PhD

  McGill University

  STUDY CHAIR

• Brock A Liden, DPM

  WAFL Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 31, 2023
• Study Start: July 1, 2022
• Primary Completion: January 31, 2023
• Study Completion: June 1, 2023
• Last Updated: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)