Derm-Maxx for Diabetic Foot

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

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This randomized controlled study evaluates the adjuvant use of Derm-Maxx in patients with diabetic foot ulcers

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.

Is Derm-Maxx safe for use in humans?

Research on a similar treatment, GAM501, found it to be safe and well tolerated in patients with diabetic foot ulcers, with no evidence of toxicity. Another study on a related product, DSC127, also reported it as safe for treating diabetic foot ulcers. ^{1 2 3 4 5}

How does the treatment Derm-Maxx differ from other treatments for diabetic foot ulcers?

Derm-Maxx is unique because it combines a collagen-laminin dermal matrix with resveratrol-loaded microparticles, which helps wounds heal faster by reducing oxidative stress and inflammation, unlike standard wound care that primarily involves cleaning with saline. ^{2 3 5 6 7}

What data supports the effectiveness of the treatment Derm-Maxx for diabetic foot?

The research highlights the importance of dermatological care in preventing complications of diabetic foot syndrome, such as infections and ulcers, by maintaining skin integrity and using appropriate wound care techniques. While it doesn't specifically mention Derm-Maxx, it suggests that treatments focusing on skin care and wound management can help reduce the risk of amputations and improve outcomes for diabetic foot patients. ^{6 8 9 10 11}

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

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]

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]

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. Switzerland pubmed.ncbi.nlm.nih.gov

[Dermatological aspects in prevention and treatment of the diabetic foot syndrome]. [2008]

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

Diabetic foot ulcers: Part I. Pathophysiology and prevention. [2022]

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

Diabetic foot ulcers: Part II. Management. [2022]

4. Brazil pubmed.ncbi.nlm.nih.gov

Effects of nursing care on patients in an educational program for prevention of diabetic foot. [2022]

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

In-office management of common geriatric foot problems. [2005]

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

Treatment of nonhealing diabetic foot ulcers with a platelet-derived growth factor gene-activated matrix (GAM501): results of a phase 1/2 trial. [2022]

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

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

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

Comparative Evaluation of Clinical Efficacy and Safety of Collagen Laminin-Based Dermal Matrix Combined With Resveratrol Microparticles (Dermalix) and Standard Wound Care for Diabetic Foot Ulcers. [2022]

9. United States 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. [2021]

10. 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]

11. Russia (Federation) pubmed.ncbi.nlm.nih.gov

APPLICATION OF GRAFTSKIN TO ACCELERATE HEALING OF ULCERS IN DIABETIC FOOT SYNDROME. [2018]