DermGEN™ for Diabetic Foot Ulcers

Overseen By Idevania Costa, RN, NSWOC (S), Ph.D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: DeCell Technologies Inc.

Must not be taking: Immunosuppressants, Blood thinners

Disqualifiers: Active liver disease, Cancer, Smoking, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 20 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how well DermGEN™, a special skin graft made from donated human skin, heals diabetic foot ulcers. It compares this new treatment to the usual care typically received by people with these ulcers. The goal is to determine if DermGEN™ can improve healing, enhance quality of life, and reduce treatment costs for First Nations people with diabetic foot ulcers in Northwestern Ontario. Suitable participants have a documented history of diabetes with an ulcer present for at least two weeks, meeting specific size and health criteria. As an unphased trial, this study offers participants the chance to contribute to valuable research that could lead to better treatment options for diabetic foot ulcers.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are taking immunosuppressant medications or blood thinners, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that DermGEN™, a skin treatment made from donated human skin, has been studied for safety in treating diabetic foot ulcers. In past studies, participants used DermGEN™ without major safety issues. Researchers closely monitored side effects, although there is no direct data on these effects. Similar treatments, like Dermagraft, have been effective and generally well-tolerated, suggesting that DermGEN™ might be safe to use.

DermGEN™ is not yet approved for general use, as it is still under study to confirm its safety. Its testing in clinical trials indicates it has shown enough promise in earlier tests to continue. Participants in these trials help researchers gather important safety information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard care for diabetic foot ulcers, which typically involves wound cleaning, protective footwear, and regular dressing changes, DermGEN™ offers a unique approach. DermGEN™ is made from decellularized dermal matrix derived from donated human skin, which provides a scaffold for the body's own cells to regenerate and heal the wound more effectively. This novel method could enhance healing by promoting the growth of new skin over the ulcer, potentially speeding up recovery and reducing complications. Researchers are excited about DermGEN™ because it represents a shift from merely managing the ulcer to actively regenerating damaged tissue.

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

Research shows that DermGEN™, a special skin treatment tested in this trial, may heal diabetic foot ulcers (DFUs) more effectively than usual methods. Participants will receive either DermGEN™ or standard care. Earlier studies have linked treatments like DermGEN™ to faster healing. One study found that a similar treatment improved outcomes for non-healing wounds. This suggests DermGEN™ could enhance wound healing by providing a framework that supports new skin growth, potentially accelerating the process. Initial results are promising, but further research is needed to confirm its benefits. ^{2 6 7 8 9}

Who Is on the Research Team?

Paul F Gratzer, Ph.D.

Principal Investigator

Dalhousie University

Are You a Good Fit for This Trial?

This trial is for First Nations people with Type I or II diabetes and an active diabetic foot ulcer. Participants must be willing to wear a Total Contact Cast, have stable diabetes (HbA1C between 5.0 to 10 mmol/L), and ulcers suitable for skin grafting without deep tissue exposure. Exclusions include non-diabetes-related ulcers, certain medical conditions, immunosuppressant use, cancer not in remission for over 5 years, severe liver disease or infection, pregnancy intention during the study period, smoking habit or known allergies to specific antibiotics.

Inclusion Criteria

Participant and social support (e.g., family, caregiver) ready and willing to participate and comply with follow-up regime

I am willing to wear a Total Contact Cast for my treatment.

My diabetes is stable with HbA1C levels between 5.0 to 10 mmol/L.

Exclusion Criteria

Medical condition(s) that in the investigators' opinion make the patient inappropriate for study (e.g active liver disease)

I am currently pregnant or plan to become pregnant during the study.

My ulcer is not caused by diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either DermGEN™ or standard of care for diabetic foot ulcers

20 weeks

Weekly visits for ongoing assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DermGEN™

Trial Overview The trial compares standard wound care against the application of DermGEN™ - a decellularized dermal matrix on diabetic foot ulcers among First Nations individuals. It's a randomized study where participants are equally divided into two groups: one receiving regular care and the other getting DermGEN™ treatment alongside regular care.

How Is the Trial Designed?

Group I: DermGEN™ Experimental Treatment 1 Intervention

A decellularized dermal matrix created from donated human skin. This arm will receive the same care as the Standard of Care control arm-physical examination, wound debridement, total cast or offloading boot, non-adherent dressing (PolyMem®) for wound covering, weekly visit for ongoing assessment-with the addition of DermGEN™ onto the wound at the first visit.

Group II: Standard of Care Active Control 1 Intervention

The standard of care includes physical examination, wound debridement, total cast or offloading boot, non-adherent dressing (PolyMem®) for wound covering, weekly visit for ongoing assessment

Who Is Running the Clinical Trial?

DeCell Technologies Inc.

Lead Sponsor

Trials

1

Recruited

120+

Dalhousie University

Collaborator

Trials

177

Recruited

402,000+

Lakehead University

Collaborator

Trials

29

Recruited

3,900+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Published Research Related to This Trial

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]

The innovative intelligent insole system significantly reduced the incidence of diabetic foot ulcers by 71% over 18 months in high-risk patients compared to a control group, demonstrating its efficacy in preventing ulcer recurrence.

In patients who complied well with the system, the reduction in ulcer incidence was even greater at 86%, highlighting the potential of continuous plantar pressure monitoring and dynamic offloading guidance in managing diabetic foot health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovative intelligent insole system reduces diabetic foot ulcer recurrence at plantar sites: a prospective, randomised, proof-of-concept study. Abbott, CA., Chatwin, KE., Foden, P., et al.[2021]

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]

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/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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11010253/

A purified reconstituted bilayer matrix shows improved ... A purified reconstituted bilayer matrix shows improved outcomes in treatment of non‐healing diabetic foot ulcers when compared to the standard of care.

3. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/413223

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

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05251480?tab=history&a=1

Record History | ver. 1: 2022-02-19 | NCT05251480 This table shows all the versions of this study record arranged in order by submitted date. To view one version of the study record, click the submitted ...

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

Clinical effectiveness of an acellular dermal regenerative ... The results of this prospective, randomised, multicentre study indicate that diabetic foot ulcers treated with AM therapy have a two to three times higher ...

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

DermGEN™ for Foot Ulcers · Info for Participants While there is no direct data on DermGEN™, similar treatments like Dermagraft have shown effectiveness in healing diabetic foot ulcers faster than standard ...

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

A Feasibility and Safety Study of a Novel Human ... The purpose of this study was to determine the feasibility and safety of a novel decellularized dermal matrix (DDM) for the treatment of chronic diabetic foot ...

8. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/55/NCT02184455/Prot_ICF_000.pdf

Clinical Trial Protocol DermGEN in the treatment of non-healing diabetic foot ulcers (DFU). Adverse events incidence is the only objective regarded as a safety issue.

9. 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 ...