DERMASEAL for Diabetic Foot Ulcers
Recruiting at 3 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: Vitruvian Medical Devices, Inc.
No Placebo Group
Trial Summary
What is the purpose of this trial?
This trial is testing DERMASEAL, a special bandage with silver particles, on diabetic patients with foot ulcers that don't heal. The silver helps kill bacteria and promotes healing. The main goal is to see if it is safe to use. Silver-containing dressings have been used for their antimicrobial properties in wound care, including diabetic foot ulcers, to reduce infection and promote healing.
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.
What data supports the idea that DERMASEAL for Diabetic Foot Ulcers is an effective treatment?
The available research does not provide specific data on DERMASEAL for Diabetic Foot Ulcers. However, one study compared a similar treatment, DermACELL, to conventional care and another treatment, Graftjacket, showing that DermACELL had a higher healed ulcer rate. This suggests that treatments like DERMASEAL might also be effective, but more specific research on DERMASEAL is needed to confirm its effectiveness.12345
What safety data exists for DERMASEAL treatment for diabetic foot ulcers?
The provided research does not contain specific safety data for DERMASEAL or its use in treating diabetic foot ulcers. The articles discuss general safety monitoring in dermatologic surgery, adverse events in dermal fillers, and the importance of patient-reported outcomes in dermatology drug development, but none directly address DERMASEAL or its safety profile.678910
Eligibility Criteria
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
See 9 more
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
See 17 more
Treatment Details
Interventions
- DERMASEAL (Other)
Trial OverviewThe 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.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Group I: Plasma FilmExperimental Treatment2 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: DERMASEALExperimental Treatment2 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 Control1 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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vitruvian Medical Devices, Inc.
Lead Sponsor
Trials
2
Recruited
40+
Findings from Research
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 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]
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]
References
Predictors of amputation in diabetics with foot ulcer: single center experience in a large Turkish cohort. [2022]
Assessing the outcome of the management of diabetic foot ulcers using ulcer-related and person-related measures. [2022]
Diabetic foot ulcers: Part II. Management. [2022]
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. [2020]
Dressing and Diabetic Foot Ulcers: A Current Review of the Evidence. [2021]
Automobile injury: a common familiar risk for presenting and comparing risks in dermatology. [2019]
Learning curves: historical trends of FDA-reported adverse events for dermal fillers. [2019]
A report from the 69th annual meeting of the American Academy of Dermatology (February 4-8, 2011 - New Orleans, Louisiana, USA). [2018]
Impact of Measuring Patient-Reported Outcomes in Dermatology Drug Development. [2018]
Detecting adverse events in dermatologic surgery. [2019]
Advances in Dermoepidermal Skin Substitutes for Diabetic Foot Ulcers. [2020]
DermACELL: Human Acellular Dermal Matrix Allograft A Case Report. [2017]
Dermal substitute template use in diabetic foot ulcers: case reports. [2012]
A Prospective, Multicenter, Single-Arm Clinical Trial for Treatment of Complex Diabetic Foot Ulcers with Deep Exposure Using Acellular Dermal Matrix. [2020]