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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests DermGEN™, a new treatment for diabetic foot ulcers. It aims to determine if DermGEN™, a special skin graft made from human skin, can accelerate wound healing by supporting the skin's natural structure. The trial seeks individuals with diabetic foot ulcers that have persisted for at least two weeks, have shown minimal healing, and are large enough to qualify. Participants should have good blood flow to the foot and be prepared to follow the study plan. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance healing for many.

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 prior data suggests that DermGEN™ is safe for treating diabetic foot ulcers?

Research has shown that DermGEN™ is safe for use. In one study, wounds reduced by an average of 80.3% over 16 weeks, with no reported problems. This suggests DermGEN™ could be a safe option for treating diabetic foot ulcers. Participants in other trials also experienced no major side effects, further supporting its safety. DermGEN™ is a specialized skin treatment that accelerates wound healing by stabilizing the wound. Overall, the evidence suggests DermGEN™ is safe for humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about DermGEN™ for foot ulcers because it offers a new approach to healing. Unlike traditional treatments that often rely on dressings, ointments, or surgical options, DermGEN™ uses a regenerative tissue matrix, which is designed to promote faster and more effective healing by providing a scaffold for new tissue growth. This innovative mechanism can potentially reduce healing time and improve outcomes for patients, making it a promising alternative to existing therapies.

What evidence suggests that DermGEN™ is effective for diabetic foot ulcers?

Research has shown that DermGEN™, the treatment under study in this trial, may aid in healing diabetic foot ulcers. In one study, patients' wounds shrank by an average of 80.3% over 16 weeks without complications. Another study found that 75% of wounds completely healed after 12 weeks. Additionally, a different group of patients experienced an average wound reduction of 87% in just four weeks. These results suggest that DermGEN™ could effectively speed up the healing of diabetic foot ulcers. ^{2 5 6 7 8}

Who Is on the Research Team?

Graham Roche-Nagle, MD

Principal Investigator

University Health Network, Toronto

Are You a Good Fit for This Trial?

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.

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05251480

NCT05251480 | Examining the Effectiveness of DermGEN ... The study will examine the effectiveness of a decellularized dermal matrix (i.e., DermGEN™) in improving wound healing, quality of life and associated costs ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7951349/

Clinical effectiveness of an acellular dermal regenerative ... Fifteen (71·4%) patients in the control group experienced a decrease in ulcer size, while five (23·8%) increased in size (mean healing percent = −30·37 ± 19·89, ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1499267122000739

A Feasibility and Safety Study of a Novel Human ... The mean and median reductions in wound area at 4 weeks posttreatment were 87% and 100%, respectively. The proportion of patients having achieved complete ...

4. withpower.com withpower.com/trial/dermgen-for-foot-ulcers-317e6

DermGEN™ for Foot Ulcers · Info for Participants 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 ...

5. fastracjournal.org fastracjournal.org/article/S2667-3967(21)00136-1/fulltext

Evaluation of wound healing of diabetic foot ulcers in a ... At the end of the 12-week treatment period, 18 of 24 wounds (75%) reported complete wound closure. The average reduction in wound surface area ...

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT00521937

NCT00521937 | Efficacy and Safety Study of DERMAGEN ... Also called a data safety and ... Safety of DERMAGEN® Versus Conventional Treatment in the Treatment of Diabetic Neuropathic Foot Ulcer.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02184455

Feasibility Study of DermGEN for Diabetic Foot Ulcer ... The purpose of this clinical trial is to perform a limited pilot study to determine the safety and feasibility of DermGEN in the treatment of non-healing ...

8. ctv.veeva.com ctv.veeva.com/study/examining-the-effectiveness-of-dermgen-in-the-treatment-of-diabetic-foot-ulcers-in-first-nations-pe

Examining the Effectiveness of DermGEN™ in the Treatment ... The study will examine the effectiveness of a decellularized dermal matrix (i.e., DermGEN™) in improving wound healing, quality of life and ...