Study to Assess the Safety of DERMASEAL for Diabetic Foot Ulcers (NCT05586542) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study to Assess the Safety of DERMASEAL for Diabetic Foot Ulcers
United States26 participantsStarted 2022-10-03
Plain-language 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.
Who can participate
Age range21 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Men or women ≥ 21 years of age.
✓. The subject is able and willing to adhere to study procedures and informed consent is obtained.
✓. A non-healing ulcer that is diabetic and neuropathic in origin, located on the foot as defined by beginning \>50% below the malleoli of the ankle.
✓. Target ulcer surface area between 1 - 10 cm2 after debridement with no active infection.
✓. Patients with Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per American Diabetes Association.)
✓. Additional wounds may be present but not within 2 cm of the target ulcer.
✓. Patient has adequate arterial perfusion of the affected extremity as demonstrated by any one of the following within the past 90 days from the time of screening:
✓. Target ulcer involves a full thickness skin loss, WITHOUT exposure of tendon, muscle, or bone (University of Texas Grade 1-A or Wagner Grade 1) that has been present ≥ 4 weeks. at the time of screening.
Exclusion criteria
✕. Suspected or confirmed signs/symptoms of wound infection (subjects may be rescreened if the infection has been treated.) Infection is defined as, for example:
✕. Patients presenting with an ulcer probing to tendon, capsule or bone (University of Texas Grade 2 or 3 or deep Wagner 2 or 3).
. Hypersensitivity to silver or fresh frozen plasma.
✕. The subject was previously entered into this study or had participated in any study drug or medical device study within 30 days of screening.
✕. Currently on a treatment regimen or medications which in the opinion of the investigator are known to interfere with wound healing (for example: cancer chemotherapy or equivalent immunosuppressants, systemic steroids \> 10 days of treatment, cytostatic drugs, cyclooxygenase-2 inhibitors, or radiation therapy).
✕. Excessive lymphedema that in the opinion of the investigator will interfere with wound healing.
✕. A cognitive, physical, or psychological condition interfering with subject's ability to comply with the treatment regimen.
✕. Active Charcot foot or unstable Charcot that in the opinion of the investigator will inhibit wound healing.