Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
Study NCT ID:
NCT06227520
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-29
First Post:
2024-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acellular Dermal Allograft for Chronic Diabetic Wounds
Sponsor:
University Health Network, Toronto
Organization:
Study Overview
Official Title:
Acellular Dermal Allograft for Chronic Diabetic Wounds
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: