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 range
21 Years
Sex
ALL
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:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.