Acellular Dermal Allograft for Chronic Diabetic Wounds

NCT06227520 | Not Yet Recruiting

• 1 other identifier: 23-5933
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the efficacy of a novel decellularized dermal matrix (DDM) DermGEN™ for the treatment of diabetic foot ulcers (DFU). Despite several advances in wound treatments, hard-to-heal wounds, such as diabetic foot ulcer, still require 12 to 16 weeks to achieve complete closure. Although the focus of most research into wound-healing treatments has been on moisture and bacterial control, new approaches that target the instability of the extracellular matrix (ECM) in a wound are timely and much needed, particularly for hard-to-heal wounds such as DFUs. Innovative technologies that provide ECM interactions halt the chronic inflammatory cycle and stimulate cells that allow for tissue regeneration and wound healing. DermGEN™ is a human dermal allograft that has been minimally processed from human skin to remove epidermal and dermal cells while preserving the structure and intrinsic properties of the natural extracellular matrix of the dermis. This has potential to facilitate a shorter wound-healing time.

Conditions

Wound Heal; Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Wound Healing

  Percentage of Wound Area Reduction Compared to Baseline

  20 weeks

Secondary Outcomes (3)

• Wound healing

  1 year

• Adverse events

  20 weeks

• Ulcer Reoccurrence

  1 year

Study Arms (1)

Dermgen

EXPERIMENTAL

Application of Dermgen

Other: decellularized dermal matrix

Interventions

decellularized dermal matrix OTHER

Application of Wound bed

Also known as: Dermgen

Dermgen

Eligibility Criteria

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

You may qualify if:

• Patient's ulcer has been present for a minimum of 2 weeks as of Day 0.
• Study ulcer has healed \<30% in size during the 2 weeks prior to Day 0.
• Ulcer area is ≥1 cm2 prior to debridement at Day 0 of study.
• Ulcer extends through dermis and into subcutaneous tissue but without exposure of muscle, tendon, bone or joint capsule.
• Ulcer is free of necrotic debris and clinical infection, and is comprised of healthy vascular tissue suitable for skin grafting on Day 0.
• Patient has adequate circulation to the foot as evidenced by toe pressure measurement.
• Female patients are not pregnant at time of, or during study.
• Patient and caregiver ready and willing to participate and comply with follow-up regime.
• Patient or legal representative has read and signed the Institutional Ethics Review Board approved informed consent form.

You may not qualify if:

• Evidence of gangrene on affected foot.
• Ulcer is over Charcot deformity (fractures or dislocation).
• Ulcer is non-diabetic in etiology.
• Patient receiving oral or parenteral corticosteroids, immunosuppression or cytotoxic agents, or is anticipated to require such agents during study.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (1)

• Costa IG, Glazebrook M, Lu S, McLaren AM, Gratzer PF. A Feasibility and Safety Study of a Novel Human Decellularized Dermal Matrix to Accelerate Healing of Neuropathic Diabetic Foot Ulcers in People With Type 1 and Type 2 Diabetes. Can J Diabetes. 2022 Oct;46(7):671-677. doi: 10.1016/j.jcjd.2022.03.010. Epub 2022 Apr 6.

  PMID: 35945125 BACKGROUND

MeSH Terms

Conditions

Diabetic Foot

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

Study Officials

• Graham Roche-Nagle, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Graham Roche-Nagle, MD

CONTACT

416-340-5332; Graham.Roche-Nagle@uhn.ca

Naomi Eisenberg, MEd

CONTACT

416-340-4800; Naomi.Eisenberg@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: January 29, 2024
• Study Start: April 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)