Acellular Dermal Allograft for Chronic Diabetic Wounds

NCT ID: NCT06227520

Last Updated: 2024-01-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2026-12-30

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.

Detailed Description

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. The resulting sterile decellularized scaffold provides a support for cellular repopulation and vascularization at the surgical site to facilitate integumental wound healing. Unlike other tissue-derived ECM-based products, such as acellular and decellularized matrices where treatments require anywhere from 6 to 10 reapplications of the product to achieve wound-closure rates of only 35% to 55% (16) DermGEN™ only requires one. A feasibility study has shown that 82% of participants (9 of 11 subjects) who had their DFU (1 ulcer/participant) treated with a single application of DDM (DermGEN) achieved complete wound closure between 2 and 8 weeks, with a mean 3.3 weeks and median of 2.3 weeks (https://doi.org/10.1016/j.jcjd.2022.03.010). The investigators have used this technology on a number of cases with good success. The investigators wish to gather further data with this study.

The purpose of this clinical trial is to perform a pilot study to determine the efficacy of DermGEN in the treatment in acute and non-healing diabetic foot ulcers (DFU). This will be a one-arm prospective study. It is hypothesized that DermGEN treatment will result in positive healing outcomes with no significant adverse effects. We anticipate to enroll 30 patients.

After enrolment and an initial assessment (time 0 data), participants will be treated with a single application of the DDM following standard-of-care procedures that include debridement of the DFU to provide healthy bleeding tissue margins. Then, it is applied with the dermal side in contact with the ulcer bed and covered by a bolster dressing. The bolster dressing is changed weekly during the follow-up. Follow-up assessments are conducted at 1, 2, 3, 4, 12 and 20 weeks. Digital photography is used to capture the appearance and size of the ulcer at each visit.

Conditions

Wound Heal; Diabetic Foot Ulcer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dermgen

Application of Dermgen

Group Type: EXPERIMENTAL

decellularized dermal matrix

Intervention Type: OTHER

Application of Wound bed

Interventions

decellularized dermal matrix

Application of Wound bed

Intervention Type: OTHER

Other Intervention Names

Dermgen

Eligibility Criteria

Inclusion Criteria

1. Patient's ulcer has been present for a minimum of 2 weeks as of Day 0.

2. Study ulcer has healed <30% in size during the 2 weeks prior to Day 0.

3. Ulcer area is ≥1 cm2 prior to debridement at Day 0 of study.

4. Ulcer extends through dermis and into subcutaneous tissue but without exposure of muscle, tendon, bone or joint capsule.

5. Ulcer is free of necrotic debris and clinical infection, and is comprised of healthy vascular tissue suitable for skin grafting on Day 0.

6. Patient has adequate circulation to the foot as evidenced by toe pressure measurement.

7. Female patients are not pregnant at time of, or during study.

8. Patient and caregiver ready and willing to participate and comply with follow-up regime.

9. Patient or legal representative has read and signed the Institutional Ethics Review Board approved informed consent form.

Exclusion Criteria

1. Evidence of gangrene on affected foot.

2. Ulcer is over Charcot deformity (fractures or dislocation).

3. Ulcer is non-diabetic in etiology.

4. Patient receiving oral or parenteral corticosteroids, immunosuppression or cytotoxic agents, or is anticipated to require such agents during study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Graham Roche-Nagle, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

University Health Network

Toronto, Ontario, Canada

Countries

Canada

Central Contacts

Graham Roche-Nagle, MD

Role: CONTACT

Graham.Roche-Nagle@uhn.ca

416-340-5332

Naomi Eisenberg, MEd

Role: CONTACT

Naomi.Eisenberg@uhn.ca

416-340-4800 ext. 8623

Facility Contacts

Graham Roche-Nagle, MD

Role: primary

Graham.Roche-Nagle@uhn.ca

416-340-5332

Naomi Eisenberg, MEd

Role: backup

Naomi.Eisenberg@uhn.ca

416-340-4800 ext. 8623

References

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.

Reference Type: BACKGROUND

PMID: 35945125 (View on PubMed)

Other Identifiers

23-5933

Identifier Type: -

Identifier Source: org_study_id