Derm-Maxx for Diabetic Foot

Not yet recruiting at 11 trial locations

Overseen By Sarah Moore, BSN, MBE

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Capsicure, LLC

Must not be taking: Immunosuppressants, Chemotherapy, Topical steroids

Disqualifiers: Malignancy, Cardiovascular, Renal, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Derm-Maxx to determine its effectiveness in healing diabetic foot ulcers when added to standard care. The trial includes two groups: one receives standard treatment, which involves cleaning and dressing the wound, while the other receives the same treatment with the addition of Derm-Maxx. Ideal candidates have had a diabetic foot ulcer for more than four weeks but less than a year and have not experienced significant healing recently. Participants should be prepared to follow the study's procedures and have adequate blood circulation in their feet. As an unphased trial, this study provides a unique opportunity to contribute to medical research and potentially benefit from a new treatment approach.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressants, cytotoxic chemotherapy, or topical steroids, you may need to stop them at least 30 days before joining the trial.

What prior data suggests that Derm-Maxx is safe for use in diabetic foot ulcers?

Research on treatments similar to Derm-Maxx, such as GAM501, has shown them to be safe and well-tolerated in people with diabetic foot ulcers. Those studies found no signs of toxicity, indicating the treatment did not cause harmful effects. This suggests that Derm-Maxx might also be safe. However, each treatment can work differently, so it's important to follow the study's findings for the best guidance on safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Derm-Maxx for diabetic foot treatment because it offers a novel approach by integrating seamlessly with the standard of care. Unlike traditional methods that focus on debridement, offloading, and moisture balance, Derm-Maxx introduces a new device that could enhance healing within just 12 weeks. This device-based addition has the potential to accelerate recovery and improve outcomes for patients, setting it apart from existing options.

What evidence suggests that Derm-Maxx might be an effective treatment for diabetic foot ulcers?

Studies have shown promising results for Derm-Maxx in treating diabetic foot ulcers. Participants in this trial may receive Derm-Maxx alongside standard care. One study found that 65% of patients using Derm-Maxx healed their ulcers within six weeks, compared to only 5% of those receiving standard care alone. Another study found that 47 out of 61 participants with large diabetic foot ulcers developed new tissue using a treatment similar to Derm-Maxx. These findings suggest that Derm-Maxx could significantly improve healing rates for diabetic foot ulcers. ^{1 2 3 5 6}

Who Is on the Research Team?

Windy Cole, DPM

Principal Investigator

Capsicure, LLC

Sarah Moore, BSN, MBE

Principal Investigator

Capsicure, LLC

Are You a Good Fit for This Trial?

This trial is for adults with Type I or II Diabetes who have a diabetic foot ulcer that hasn't improved with standard treatments. The ulcer should be on the foot, present for 4 weeks to less than a year, and not healing well. Participants must have good blood flow to their feet and be willing to follow study rules.

Inclusion Criteria

Is your foot ulcer between 2-25cm2? (ie is it bigger than a quarter but smaller than a tennis ball?)

Has your foot ulcer been present for at least a month but no longer than a year?

Exclusion Criteria

Is your foot ulcer infected or has it been infected recently?

Does your foot ulcer expose tendon or bone?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Run-in

Participants complete a 2-week run-in period prior to treatment allocation

2 weeks

Treatment

Participants receive Derm-Maxx and standard of care or standard of care alone for 12 weeks

12 weeks

Weekly visits (± 3 days)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Derm-Maxx

Trial Overview The study tests Derm-Maxx as an additional treatment for diabetic foot ulcers alongside usual care. It's a randomized controlled trial, meaning patients are randomly assigned to receive either Derm-Maxx or no extra treatment in addition to their current care.

How Is the Trial Designed?

Group I: Derm-Maxx as an addition to standard of care Experimental Treatment 1 Intervention

Device exposure is estimated to be a maximum of 12 weeks

Group II: Standard of care Active Control 1 Intervention

Debridement, offloading, and proper moisture balance dressings

Who Is Running the Clinical Trial?

Capsicure, LLC

Lead Sponsor

Trials

2

Recruited

300+

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]

An interdisciplinary team approach is crucial for managing diabetic foot ulcers, focusing on correctable risk factors like vascular supply, infection control, and pressure redistribution, which can significantly reduce the risk of amputations.

Early detection and comprehensive management of skin integrity issues, such as calluses or ulcers, are essential to prevent complications and improve patient outcomes in diabetic foot care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetic foot ulcers: Part II. Management. Alavi, A., Sibbald, RG., Mayer, D., et al.[2022]

In a Phase 2 clinical trial involving 172 patients with diabetic foot ulcers, the topical treatment NorLeu(3)-A(1-7) (DSC127) demonstrated significant efficacy, with 80% of ulcers treated with the 0.03% concentration completely healing by Week 12, compared to only 40% in the placebo group.

DSC127 was found to be safe, with no significant adverse events reported, and it accelerated healing time, reducing the median healing duration from 22 weeks in the placebo group to just 8.5 weeks for the 0.03% DSC127 group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NorLeu3-A(1-7) stimulation of diabetic foot ulcer healing: results of a randomized, parallel-group, double-blind, placebo-controlled phase 2 clinical trial. Balingit, PP., Armstrong, DG., Reyzelman, AM., 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06455475

Derm-Maxx in Patients With Diabetic Foot Ulcers ... Primary efficacy endpoints include percentage change in ulcer size at 12 weeks along with the proportion of participants achieving complete wound closure.

2. withpower.com withpower.com/trial/phase-diabetic-foot-5-2024-28000

Derm-Maxx for Diabetic Foot · Info for Participants 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 ...

3. researchgate.net researchgate.net/publication/397135431_Evaluation_of_acellular_human_dermis_graft_on_the_healing_rate_of_chronic_diabetic_foot_ulcers_an_interim_analysis_of_the_Derm-Maxx_trial

an interim analysis of the Derm-Maxx trial At 6 weeks, the primary outcome time, 65% of the HR-ADM-treated DFUs healed (13/20) compared with 5% (1/20) of DFUs that received SOC alone. At ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7016477/

The Efficacy and Safety of Acellular Matrix Therapy for ... Acellular matrix (AM) therapy has shown promise in the treatment of diabetic foot ulcers (DFUs) in several studies.

5. cms.gov cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=36377

LCD - Skin Substitute Grafts/Cellular and Tissue-Based ... Diabetic foot ulcers may affect up to 6% of Medicare beneficiaries with either Type I or Type II diabetes. Chronic wounds such as DFUs and VLUs impact patient ...

6. diabetesjournals.org diabetesjournals.org/care/article/48/6/966/158230/Cellular-Versus-Acellular-Matrix-Products-for

Cellular Versus Acellular Matrix Products for Diabetic Foot ... To determine whether cellular matrix (CM) products result in better healing rates than acellular matrix (ACM) products for nonhealing diabetic foot ulcers.