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Plasma Film for Foot Ulcer
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
Study Summary
This trial tests the safety of a new treatment for non-healing diabetic foot ulcers. 24 people will receive up to 4 weeks of treatment & be followed for 12 wks.
Eligible Conditions
- Diabetic Foot Ulcers
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse events
Secondary outcome measures
Injury wounds
Cost
Wound area change
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Plasma FilmExperimental Treatment2 Interventions
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.
Wash the wound once more with saline to remove remaining debris and confirm hemostasis is achieved, as needed.
Measure wound after debridement.
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.
Place soft silicone contact layer dressing to cover over the wound, secured with adhesive strips.
Cover the contact layer with a hydroconductive wound dressing secured with kerlix gauze and adhesive tape.
Apply the Foot Defender® boot.
Group II: DERMASEALExperimental Treatment2 Interventions
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.
Wash the wound once more with saline to remove remaining debris and confirm hemostasis is achieved, as needed.
Measure wound after debridement.
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.
Place soft silicone contact layer dressing to cover over the wound, secured with adhesive strips.
Cover the contact layer with a hydroconductive wound dressing secured with kerlix gauze and adhesive tape.
Apply the Foot Defender® boot.
Group III: Standard of Care (SOC)Active Control1 Intervention
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.
Wash the wound once more with saline to remove remaining debris and confirm hemostasis is achieved, as needed.
Measure wound after debridement.
Place soft silicone contact layer dressing to cover over the wound, secured with adhesive strips.
Cover the contact layer with a hydroconductive wound dressing secured with kerlix gauze and adhesive tape.
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
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the primary aims of this medical study?
"Vitruvian Medical Devices, Inc., the sponsor of this trial, has indicated that Adverse events will be monitored as the primary outcome data over 16 weeks. Furthermore, economic Cost associated with treatment along with Wound area reduction and Wound healing in post-treatment weeks 1 through 4 are being assessed for secondary outcomes."
Answered by AI
Has the FDA granted authorization for DERMASEAL?
"Based on the available evidence, our team at Power gave DERMASEAL a safety rating of 1. This is due to it being in Phase 1 trials, indicating that there are limited data points demonstrating its efficacy and security."
Answered by AI
Are there any vacancies left in this medical trial?
"According to records on clinicaltrials.gov, this medical research is still seeking participants with the trial having first been posted on October 3rd 2022 and most recently revised on October 19th 2022."
Answered by AI
What is the current sample size for this trial?
"In order for this trial to reach its objectives, a total of 24 individuals who meet the inclusion criteria must be recruited. This project is sponsored by Vitruvian Medical Devices, Inc., and will be conducted at two locations: Lower Extremity Institute for Research and Therapy in Boardman, Ohio; as well as Limb Preservation Platform in Fresno California."
Answered by AI
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