DermGEN™ for Foot Ulcers

Overseen By Naomi Eisenberg, MEd

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Must not be taking: Corticosteroids, Immunosuppressants, Cytotoxic agents

Disqualifiers: Gangrene, Charcot deformity, Non-diabetic ulcers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 1 day

30 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you do not take oral or injected corticosteroids, immunosuppressants, or cytotoxic agents during the study. If you are currently on these medications, you would need to stop taking them to participate.

What data supports the effectiveness of the treatment DermGEN™ for foot ulcers?

While there is no direct data on DermGEN™, similar treatments like Dermagraft have shown effectiveness in healing diabetic foot ulcers faster than standard treatments, with a higher percentage of ulcers healed within a year. ^{1 2 3 4 5}

How is the treatment DermGEN™ for foot ulcers different from other treatments?

DermGEN™ is unique because it is an acellular dermal matrix, which means it uses a framework of skin cells without the cells themselves to help heal foot ulcers. This approach is different from traditional treatments that may not use such advanced bioengineered materials. ^{1 2 6 7 8}

What is the purpose of this trial?

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.

Research Team

Graham Roche-Nagle, MD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

This trial is for individuals with chronic diabetic foot ulcers. Participants should have a wound that's hard to heal, typically taking more than 12 weeks to close. The study seeks people who haven't had success with standard treatments focused on moisture and bacterial control.

Inclusion Criteria

My ulcer has been present for at least 2 weeks.

My ulcer reaches into the layer beneath my skin but does not expose muscle or bone.

My foot has good blood flow.

Exclusion Criteria

I am currently taking or might need steroids, immunosuppressants, or chemotherapy during the study.

I have gangrene on my foot.

My ulcer is over a bone deformity in my foot.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single application of DermGEN following standard-of-care procedures

1 day

1 visit (in-person)

Follow-up

Participants are monitored for wound healing progress with weekly assessments

20 weeks

6 visits (in-person) at 1, 2, 3, 4, 12, and 20 weeks

Long-term follow-up

Participants are monitored for ulcer reoccurrence and adverse events

1 year

Treatment Details

Interventions

• DermGEN™

Trial Overview The trial is testing DermGEN™, a new type of treatment made from human skin but without any cells (decellularized dermal matrix). It aims to help heal wounds by providing structure and support that can stop long-term inflammation and encourage tissue regeneration.

Participant Groups

Group I: Dermgen Experimental Treatment 1 Intervention

Application of Dermgen

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Findings from Research

In a study of 61 participants with large diabetic foot ulcers (DFUs), the acellular dermal matrix allograft DermACELL (D-ADM) achieved 100% granulation in 47 participants within an average of 4 weeks, demonstrating its efficacy in promoting wound healing.

The treatment resulted in an average wound area reduction of 80.3% over 16 weeks, with no complications reported, indicating that D-ADM is a safe option for managing complex DFUs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective, Multicenter, Single-Arm Clinical Trial for Treatment of Complex Diabetic Foot Ulcers with Deep Exposure Using Acellular Dermal Matrix. Cazzell, S., Moyer, PM., Samsell, B., et al.[2020]

Custom-made cushioned footwear can reduce the risk of ulcer relapses in diabetic patients by approximately 50%, based on observations from 217 patients across various centers.

There is a need for more precise and standardized long-term studies to evaluate the effectiveness of such footwear, including better monitoring of foot pressure during walking to ensure quality control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Quality control and quality assurance in therapeutic shoes for the diabetic foot]. Chantelau, E., Jung, V.[2006]

In a 16-week study involving 168 patients, the human acellular dermal matrix DermACELL showed a significantly higher healing rate for diabetic foot ulcers compared to conventional care (67.9% vs 48.1%).

DermACELL also demonstrated a greater average reduction in wound area compared to both conventional care and another acellular dermal matrix, Graftjacket, indicating its potential as an effective treatment option for these ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healing Rates in a Multicenter Assessment of a Sterile, Room Temperature, Acellular Dermal Matrix Versus Conventional Care Wound Management and an Active Comparator in the Treatment of Full-Thickness Diabetic Foot Ulcers. Walters, J., Cazzell, S., Pham, H., et al.[2020]

A 56-year-old woman with a severe diabetic foot ulcer (Wagner grade 3) was successfully treated using a combination of advanced wound care techniques, including a new human acellular dermal matrix graft called DermACELL.

The treatment not only healed the ulcer but also helped save her limb and restore her ability to perform daily activities, highlighting the efficacy of DermACELL in managing complex diabetic wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

DermACELL: Human Acellular Dermal Matrix Allograft A Case Report. Cole, WE.[2017]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Prospective, Multicenter, Single-Arm Clinical Trial for Treatment of Complex Diabetic Foot Ulcers with Deep Exposure Using Acellular Dermal Matrix. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of silver foam combined with Dermlin wound healing dressing on inflammation and quality of life in patients with diabetic lower limb ulcers. [2023]

3. Ireland pubmed.ncbi.nlm.nih.gov

Recombinant human epidermal growth factor (REGEN-D 150): effect on healing of diabetic foot ulcers. [2007]

4. Germany pubmed.ncbi.nlm.nih.gov

[Quality control and quality assurance in therapeutic shoes for the diabetic foot]. [2006]

5. France pubmed.ncbi.nlm.nih.gov

Cost-effectiveness modeling of Dermagraft for the treatment of diabetic foot ulcers in the french context. [2004]

6. United States pubmed.ncbi.nlm.nih.gov

Combining bioengineered human dermal replacement and multilayered compression dressings to manage ulcers in a person with diabetes mellitus: a case study. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Healing Rates in a Multicenter Assessment of a Sterile, Room Temperature, Acellular Dermal Matrix Versus Conventional Care Wound Management and an Active Comparator in the Treatment of Full-Thickness Diabetic Foot Ulcers. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

DermACELL: Human Acellular Dermal Matrix Allograft A Case Report. [2017]