Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05586542
Other study ID # VMD2022-001
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date October 3, 2022
Est. completion date March 30, 2025

Study information

Verified date June 2024
Source Vitruvian Medical Devices, Inc.
Contact Hobart W Harris, MD, MPH
Phone (415) 514-3891
Email hobartwharris@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to determine the safety of DERMASEAL for the treatment of non-healing, neuropathic diabetic foot ulcers. The main outcome measure is safety. A total of twenty-four (24) participants will be randomized to receive up to four (4) consecutive weeks of treatment with either standard of care (SOC), plasma film + SOC, or plasma film containing silver microparticles (DERMASEAL) + SOC, with a final follow-up visit 12 weeks after the last treatment.


Description:

A double-blind, randomized, placebo-controlled, multi-center, phase 1 study to evaluate the safety of the DERMASEAL advanced wound care dressing in the treatment of non-healing diabetic foot ulcers located distal to the malleolus in subjects with controlled diabetes mellitus and without significantly compromised arterial circulation. Subjects will be randomized in a 1:1:2 ratio to one of 3 treatment groups: - SOC alone (n=6) - SOC + plasma film (n=6) - SOC + DERMASEAL (n=12) A subject's study duration will be up to a total of 18 weeks from screening to end of study. This includes a two-week active run-in followed by up to 4 weeks of treatment, plus a final follow-up visit 12 weeks after the last treatment. The primary endpoint is safety of topically applying a plasma film containing metallic silver microparticles plus fibrin in patients with chronic, non-healing neuropathic diabetic foot ulcers. Secondary endpoints to be assessed in each group include: 1. Percent of study wounds healed during the post-treatment weeks 1 through 4, 2. Time to complete wound closure, 3. Percent area reduction during the post-treatment weeks 2, 4, 6 and 16, and 4. Cost of treatment


Read more »

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
DERMASEAL
a novel skin substitute formulated as planar, thin film
Biological:
Plasma Film
a planar, thin film made from human plasma
Other:
Standard of Care
standard procedures for managing diabetic foot ulcers including debridement of unhealthy tissue and maintenance of a moist wound environment

Locations

Country Name City State
United States Lower Extremity Institute for Research and Therapy, LLC Boardman Ohio
United States Limb Preservation Platform, Inc. Fresno California
United States Futuro Clinical Trials, LLC McAllen Texas
United States Doctors Research Network South Miami Florida

Sponsors (1)

Lead Sponsor Collaborator
Vitruvian Medical Devices, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse events Review of adverse events associated with the topical application of a plasma film containing metallic silver microparticles in patients with chronic non-healing neuropathic diabetic foot ulcers. 16 weeks
Secondary Wound healing Percent of study wounds healed during the post-treatment weeks 1 through 4. 4 weeks
Secondary Complete wound closure Time to complete wound closure. 16 weeks
Secondary Wound area change Percent area change during the post-treatment weeks 2, 4, 6 and 16 16 weeks
Secondary Cost Total indirect and direct costs of subject treatment during the study period 16 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT03942081 - Diabetic Foot Ulcer Imaging- Study 2 N/A
Not yet recruiting NCT06023810 - The Effect of Motivational Interviewing on Treatment Adherence, Self-Efficacy, and Satisfaction in Individuals With Diabetic Foot Ulcers N/A
Recruiting NCT02838784 - Efficacy and Safety of Artacent™ for Treatment Resistant Lower Extremity Venous and Diabetic Ulcers N/A
Terminated NCT01729286 - Health Economic Assessment of Lower Extremity Diabetic (HEALED) Ulcers With PriMatrix N/A
Completed NCT01699100 - Reduction of Plantar Pressure in Neuropathic Diabetic Foot Patients Using Insoles With Removable Pegs Design N/A
Completed NCT05908968 - Assessing the Effects of ELO Water on Diabetic Foot Ulcers N/A
Completed NCT02581488 - Use of Santyl in Diabetic Foot Ulcers Phase 4
Completed NCT02334241 - The Sorbact® Antimicrobial Dressing in the Holistic Wound Management Of Diabetic Foot ulCers (Phase III Study) N/A
Completed NCT01956162 - Evaluation of a New Device "Orthèse Diabète" in the Healing of Foot Ulcers in Diabetic Patients N/A
Completed NCT00796744 - Safety and Efficacy Study of DSC127 in Treating Subjects With Diabetic Ulcers Phase 2
Recruiting NCT04210089 - Total Contact Soft Cast in Diabetic Foot Ulcers N/A
Completed NCT02647346 - In-Home Assessment of a Smart Foot Mat for Prevention of Diabetic Foot Ulcers N/A
Completed NCT01480362 - Treatment Study of Negative Pressure Wound Therapy for Diabetic Foot Wounds N/A
Terminated NCT01013792 - A Comparison of an Investigational Dressing to Tegaderm Matrix Wound Dressing in the Management of Diabetic Foot Ulcers N/A
Completed NCT01580917 - Dynamic Plantar Microvascular Skin Response to Compressive Loads in At-risk Diabetic and Healthy Control: a Pilot Study N/A
Completed NCT02427802 - Study of a Topical Gentamicin-Collagen Sponge Along With Systemic Antibiotic in Infected Diabetic Foot Ulcers Phase 3
Completed NCT02451722 - Evaluation of Pressure Distribution of Kyboot Shoes in Comparison to Other Foot Wear N/A
Terminated NCT01858545 - A Comparative Efficacy Study: Treatment for Non-healing Diabetic Foot Ulcers N/A
Completed NCT00516958 - Pilot Study of the Safety and Clinical Efficacy of Topical Dermacyn™ Wound Care to Treat Mild Diabetic Foot Infections Phase 2
Completed NCT03135535 - Micro-mobile Foot Compression and Diabetic Foot Phase 2