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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
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 moreAwards & 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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Who is running the clinical trial?
Vitruvian Medical Devices, Inc.Lead Sponsor
1 Previous Clinical Trials
12 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a foot condition called Charcot foot that is currently active or unstable, and it may prevent your wounds from healing properly.You have previously received radiation treatment to your foot.You have an autoimmune disease that is not under control.You have a diabetic foot ulcer that is not healing and is located on the bottom part of your foot, starting more than halfway below the ankle bone.You have wounds that are allowed, but they should not be closer than 2 cm to the main ulcer being studied.You have an ulcer on your body that is between 1-10 square centimeters in size, after it has been cleaned and there is no sign of infection.You have an ulcer that the doctor doesn't think is related to your diabetic nerve damage.You have a condition that makes it difficult for you to follow the treatment instructions due to problems with thinking, movement, or emotions.You have used treatments like hyperbaric oxygen or special dressings with growth factors or engineered tissues in the past month.You are allergic to silver or fresh frozen plasma.You have severe swelling called lymphedema that could make it difficult for wounds to heal properly.You have a foot ulcer that has reached deep tissues like tendons, joints, or bones.You have wounds caused by certain diseases or conditions affecting your blood vessels, tumors, or blood disorders. If you are taking medication to thin your blood, you will be closely monitored during the study.You have wounds that are deeper than 5 mm after cleaning with a sharp tool.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care (SOC)
- Group 2: Plasma Film
- Group 3: DERMASEAL
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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