DERMASEAL for Diabetic Foot Ulcers

Not currently recruiting at 3 trial locations

Overseen By Hobart W Harris, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Vitruvian Medical Devices, Inc.

Must not be taking: Chemotherapy, Immunosuppressants, Steroids, others

Disqualifiers: Infection, Osteomyelitis, Dialysis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called DERMASEAL for diabetic foot ulcers that resist healing. Researchers aim to ensure its safety for use. Participants will be randomly assigned to receive standard care, standard care with plasma film, or standard care with DERMASEAL, which includes silver microparticles. The study seeks individuals with diabetic foot ulcers present for at least four weeks that are not healing, but are neither infected nor too deep. Those managing diabetes with a persistent foot ulcer may find this trial suitable. As a Phase 1 trial, participants will be among the first to help researchers understand how DERMASEAL works in people.

Do I need to stop taking my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are on medications known to interfere with wound healing, like cancer chemotherapy, systemic steroids for more than 10 days, or certain other drugs. It's best to discuss your current medications with the trial investigator.

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 treatments known to interfere with wound healing, like certain cancer drugs or steroids, 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 skin treatments like DERMASEAL are generally safe for treating diabetic foot sores. In a study with over 1,500 patients, these treatments proved effective and easy for patients to manage, typically without serious side effects.

Another study with 168 patients examined a skin treatment similar to DERMASEAL. This study found that the treatment accelerated healing of diabetic foot sores without major safety concerns.

As a Phase 1 trial, the primary goal is to assess the treatment's safety for people. These trials are carefully designed to identify any issues early. So far, similar treatments have been used safely in other studies, which is a positive indication for DERMASEAL's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

DERMASEAL is unique because it introduces a novel approach to treating diabetic foot ulcers. Unlike standard care options that typically involve debridement and various dressings, DERMASEAL is applied directly to the wound bed and is designed to fit precisely within the ulcer, minimizing overlap onto healthy skin. This targeted delivery not only aims to protect the wound but also potentially enhances the healing environment by closely adhering to the wound's unique contours. Researchers are excited about DERMASEAL because it could offer a more tailored and efficient healing process, potentially speeding up recovery times while reducing complications associated with diabetic foot ulcers.

What evidence suggests that DERMASEAL might be an effective treatment for diabetic foot ulcers?

This trial will compare the effectiveness of DERMASEAL, Plasma Film, and standard care for diabetic foot ulcers. Research has shown that using a skin product like DERMASEAL, which participants in this trial may receive, can aid in healing diabetic foot sores. In a study with 168 patients, a similar product, DermACELL, helped these sores heal faster, suggesting that DERMASEAL might also accelerate wound healing.

For the Plasma Film treatment, another option in this trial, studies on platelet-rich plasma (a component of blood that aids healing) have shown positive results in healing diabetic foot sores more quickly. Specifically, 87.5% of studies found that adding platelet-rich plasma to regular care significantly improved healing. This suggests that Plasma Film might also expedite wound healing. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

Adults over 21 with Type 1 or Type 2 diabetes and a non-healing, neuropathic foot ulcer can join this trial. They must have good blood flow in the affected foot, controlled blood sugar (HbA1c <10%), and not be pregnant. People with uncontrolled anemia, recent participation in other studies, certain medications that affect wound healing, suspected skin cancer near the ulcer, severe kidney issues including dialysis, or specific allergies cannot participate.

Inclusion Criteria

Men or women ≥ 21 years of age

Patients with Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per American Diabetes Association)

The subject is able and willing to adhere to study procedures and informed consent is obtained

Exclusion Criteria

Patients with uncontrolled anemia (Hgb<10 g/dL in women; <12 g/dL in men) at Screening

Suspected or confirmed signs/symptoms of wound infection (subjects may be rescreened if the infection has been treated.) Infection is defined as, for example: i. purulence, erythema, cellulitis, excessively high temperatures in/around the ulcer, atypical smell, and/or excessive pain in/around the ulcer (infection may be treated and subject reconsidered for study participation). ii. osteomyelitis, with necrotic soft bone. (x-ray to be obtained if in the opinion of the investigator additional confirmation of diagnosis required)

The subject was previously entered into this study or had participated in any study drug or medical device study within 30 days of screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Run-in

Participants undergo a two-week active run-in period before treatment

2 weeks

Treatment

Participants receive up to four weeks of treatment with either SOC, plasma film + SOC, or DERMASEAL + SOC

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DERMASEAL

Trial Overview The study is testing DERMASEAL's safety for treating diabetic foot ulcers compared to standard care alone or combined with plasma film. Participants will receive treatment for up to four weeks and then be followed up after twelve weeks to assess safety outcomes.

How Is the Trial Designed?

Group I: Plasma Film Experimental Treatment 2 Interventions

1. Wash and sharps debride the target diabetic foot ulcer to remove all non-viable tissue, callus, epibole at wound edges, slough, and debris (at the physician's discretion). The wound margins should be excised to healthy bleeding tissue. 2. Wash the wound once more with saline to remove remaining debris and confirm hemostasis is achieved, as needed. 3. Measure wound after debridement. 4. Place an appropriately sized piece of Plasma Film onto the wound bed. The test agent should be cut to fit the interior of the wound with minimal overlap onto healthy skin. 5. Place soft silicone contact layer dressing to cover over the wound, secured with adhesive strips. 6. Cover the contact layer with a hydroconductive wound dressing secured with kerlix gauze and adhesive tape. 7. Apply the Foot Defender® boot.

Group II: DERMASEAL Experimental Treatment 2 Interventions

1. Wash and sharps debride the target diabetic foot ulcer to remove all non-viable tissue, callus, epibole at wound edges, slough, and debris (at the physician's discretion). The wound margins should be excised to healthy bleeding tissue. 2. Wash the wound once more with saline to remove remaining debris and confirm hemostasis is achieved, as needed. 3. Measure wound after debridement. 4. Place an appropriately sized piece of DERMASEAL onto the wound bed. The test agent should be cut to fit the interior of the wound with minimal overlap onto healthy skin. 5. Place soft silicone contact layer dressing to cover over the wound, secured with adhesive strips. 6. Cover the contact layer with a hydroconductive wound dressing secured with kerlix gauze and adhesive tape. 7. Apply the Foot Defender® boot.

Group III: Standard of Care (SOC) Active Control 1 Intervention

1. Wash and sharps debride the target diabetic foot ulcer to remove all non-viable tissue, callus, epibole at wound edges, slough, and debris (at the physician's discretion). The wound margins should be excised to healthy bleeding tissue. 2. Wash the wound once more with saline to remove remaining debris and confirm hemostasis is achieved, as needed. 3. Measure wound after debridement. 4. Place soft silicone contact layer dressing to cover over the wound, secured with adhesive strips. 5. Cover the contact layer with a hydroconductive wound dressing secured with kerlix gauze and adhesive tape. 6. Apply the Foot Defender® boot.

Who Is Running the Clinical Trial?

Vitruvian Medical Devices, Inc.

Lead Sponsor

Trials

2

Recruited

40+

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]

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]

The use of INTEGRA®, a collagen-glycosaminoglycan dermal substitute, shows promise in managing diabetic foot ulcers, particularly in cases with exposed tendons.

This approach aims to maximize limb salvage and reduce amputation rates, although the overall outcomes of dermal substitutes in diabetic foot ulcer treatment remain limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dermal substitute template use in diabetic foot ulcers: case reports. Alagaratnam, S., Choong, A., Loh, A.[2012]

In a study of 449 patients with diabetic foot ulcers, 65.7% of ulcers healed without amputation within 12 months, but only 45% of patients were alive, ulcer-free, and without amputation at the same time point, highlighting a significant gap between ulcer healing and overall patient health outcomes.

The findings suggest that focusing solely on ulcer-related outcomes may underestimate the true morbidity and mortality associated with diabetic foot disease, indicating a need for greater emphasis on patient-related outcomes in evaluating treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the outcome of the management of diabetic foot ulcers using ulcer-related and person-related measures. Jeffcoate, WJ., Chipchase, SY., Ince, P., et al.[2022]

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]

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]

Incorporating patient-reported outcomes (PROs) in dermatology drug trials enhances the understanding of treatment effectiveness from the patient's perspective, which is crucial for evaluating symptoms like pruritus and pain that are subjective.

The inclusion of PROs not only aids regulators in assessing the benefits of treatments but also supports manufacturers in communicating product advantages, ultimately benefiting patients, prescribers, and payers in the decision-making process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Measuring Patient-Reported Outcomes in Dermatology Drug Development. Copley-Merriman, C., Zelt, S., Clark, M., et al.[2018]

Current strategies for monitoring adverse events (AEs) in dermatologic surgery are inconsistent, with morbidity and mortality conferences being the most common reporting method, but more sensitive approaches like retrospective medical record reviews and anonymous electronic systems exist.

There is no standard for AE reporting in dermatologic surgery, highlighting the need for pilot studies to establish effective measures that can enhance AE detection and improve patient safety outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detecting adverse events in dermatologic surgery. Pinney, D., Pearce, DJ., Feldman, SR.[2019]

In a study of 574 diabetic foot ulcer episodes, key predictors of amputation included limb ischemia, osteomyelitis, gangrene, and ulcer depth, highlighting the importance of these clinical factors in patient management.

Baseline levels of inflammatory markers like C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were also significant predictors of amputation risk, suggesting that these laboratory tests can aid clinicians in assessing patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of amputation in diabetics with foot ulcer: single center experience in a large Turkish cohort. Yesil, S., Akinci, B., Yener, S., et al.[2022]

Dermoepidermal skin substitutes (DSS) have shown promising results in improving healing rates for diabetic foot ulcers (DFUs), with the best outcomes observed in specific substitutes like Epifix® and Amnioband® achieving 100% and 85% healing rates at 12 weeks, respectively.

Despite the positive effects of DSS when combined with standard care, there is significant variability in healing rates across studies, indicating a need for more targeted research to understand how factors like ulcer size and patient comorbidities influence treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in Dermoepidermal Skin Substitutes for Diabetic Foot Ulcers. Álvaro-Afonso, FJ., García-Álvarez, Y., Lázaro-Martínez, JL., et al.[2020]

A systematic review of 207 articles on diabetic foot ulcers revealed that while some newer therapies show promise, most studies were of low quality and prone to bias, indicating a need for better research standards.

There is a significant gap in the evidence supporting the effectiveness of common wound dressings and interventions, highlighting the necessity for future studies to assess both clinical and cost-effectiveness in managing diabetic foot ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dressing and Diabetic Foot Ulcers: A Current Review of the Evidence. Game, FL., Jeffcoate, WJ.[2021]

The lifetime risk of automobile injury is 32%, serving as a benchmark to compare the safety of various dermatologic treatments.

By using the risk of automobile injury as a common reference point, patients may better understand the relative safety of dermatologic interventions, potentially improving adherence to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automobile injury: a common familiar risk for presenting and comparing risks in dermatology. Oussedik, E., Hessel, AB., Feldman, SR.[2019]

The study analyzed historical adverse event (AE) data for FDA-approved dermal fillers to identify learning curves associated with new fillers, helping to differentiate between expected learning-related AEs and those due to the product's characteristics.

Understanding these learning curves can improve safety monitoring and response strategies for new fillers, ensuring that reactions to AEs are based on comprehensive data analysis rather than assumptions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Learning curves: historical trends of FDA-reported adverse events for dermal fillers. Chandawarkar, AA., Provenzano, DJ., Rad, AN., et al.[2019]

The annual meeting of the American Academy of Dermatology highlighted new research aimed at improving evidence-based treatments for skin diseases like psoriasis and atopic dermatitis, which significantly affect patients and their families.

A concerning study presented at the meeting revealed that many dermatologists experience injuries during procedures, indicating a need for better reporting and improved safety measures in the field.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A report from the 69th annual meeting of the American Academy of Dermatology (February 4-8, 2011 - New Orleans, Louisiana, USA). Rabasseda, X.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10877811/

Effectiveness and safety of dermal matrix used for diabetic foot ... The application of dermal matrix as an adjuvant therapy in conjunction with SOC effectively improved the healing process of DFUs and reduced the amputation ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38374102/

Effectiveness and safety of dermal matrix used for diabetic ... The primary outcomes analyzed included time to complete healing and complete healing rate at the final follow-up, while secondary outcomes ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05586542

Study to Assess the Safety of DERMASEAL for Diabetic ... The goal of this clinical trial is to determine the safety of DERMASEAL for the treatment of non-healing, neuropathic diabetic foot ulcers.

4. withpower.com withpower.com/trial/phase-1-diabetic-foot-9-2022-af524

DERMASEAL for Diabetic Foot Ulcers · Info for Participants In a 16-week study involving 168 patients, the human acellular dermal matrix DermACELL showed a significantly higher healing rate for diabetic foot ulcers ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05586542/study-to-assess-the-safety-of-dermaseal-for-diabetic-foot-ulcers?state=TX&city=McAllen

Study to Assess the Safety of DERMASEAL for Diabetic ... The goal of this clinical trial is to determine the safety of DERMASEAL for the treatment of non-healing, neuropathic diabetic foot ulcers.

6. ctv.veeva.com ctv.veeva.com/study/study-to-assess-the-safety-of-dermaseal-for-diabetic-foot-ulcers

Study to Assess the Safety of DERMASEAL for Diabetic Foot ... The goal of this clinical trial is to determine the safety of DERMASEAL for the treatment of non-healing, neuropathic diabetic foot ulcers.