DERMASEAL for Diabetic Foot Ulcers

Phase 1

Recruiting

Research Sponsored by Vitruvian Medical Devices, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 16 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include allergic reactions to silver (in DERMASEAL) or plasma components used in treatments. Since it's a safety trial, close monitoring will identify any additional side effects related to the interventions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 16 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~16 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse events

Secondary study objectives

Injury wounds

Cost

Wound area change

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

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