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NCT02626156 · ClinicalTrials.gov registry record · Phase 2
Cooling Leg and Foot Ulcer Skin Post Healing to Prevent Ulcer Recurrence
A Phase 2 study of Diabetic Foot and Foot Ulcer, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- Phase 2
- Development phase
- 140
- Enrollment target
- 2
- Study locations
NCT02626156: Completed Phase 2 study of Diabetic Foot and Foot Ulcer, sponsored by Medical University of South Carolina.
NCT02626156 is a Phase 2 study of Diabetic Foot and Foot Ulcer that has completed, run by Medical University of South Carolina. The registered enrollment target is 140 participants, below the 10,337-participant average among 30 other Diabetic Foot trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02626156, a Phase 2 study of Diabetic Foot and Foot Ulcer, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 140 participants
- Enrollment target
- 2
- Study locations
Study Summary
The goal of this study is to test MUSTCOOL, a home-based self-monitoring and self-management ulcer prevention intervention for patients with newly healed chronic venous leg and diabetic foot ulcers. Almost 90% of ulcers recur within 3 months of healing. During the six-month randomized clinic trial, skin temperature will be monitored daily, a maintenance dose of cooling gel pack or placebo will be applied three times weekly to the affected skin, and a bolus dose of cooling will be applied for 5 consecutive days if skin temperature becomes elevated. Outcomes on the incidence of leg ulcer recurrence, pain, physical activity and quality of life will be measured.
Primary Outcome
Number of recurrent ulcers that develop during the 6 month study period for in participants for 4 groups of patients with previously healed venous leg ulcers receiving the cooling gel pack and cooling cotton pack and those with previously healed diabetic foot ulcers receiving the cooling gel pack or cooling cotton pack.
Conditions Studied
Interventions
- DEVICE Cooling gel pack
- DEVICE Cooling cotton pack
Study Locations (2)
South Carolina
- Medical University of South Carolina - Charleston
- Spartanburg Regional Medical Center - Spartanburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2015-06-01 |
| Est. Completion | 2020-03-31 |
| Phase | Phase 2 |
What the finished NCT02626156 record still lists
NCT02626156 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 10,337-participant average among 30 other Diabetic Foot trials with a reported enrollment target (99% lower).
The record links to 8 conditions, with Diabetic Foot appearing as the primary indexed condition, and to 2 interventions - of which Cooling gel pack is the first listed.
NCT02626156 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT02626156 about?
NCT02626156 is a clinical study titled "Cooling Leg and Foot Ulcer Skin Post Healing to Prevent Ulcer Recurrence". The goal of this study is to test MUSTCOOL, a home-based self-monitoring and self-management ulcer prevention intervention for patients with newly healed chronic venous leg and diabetic foot ulcers. Almost 90% of ulcers recur within 3 months of healing. During the six-month randomized clinic trial, ...
What is the current status of trial NCT02626156?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 140 participants. The study started on 2015-06-01. Estimated completion is 2020-03-31.
What conditions does trial NCT02626156 study?
This clinical trial studies the following conditions: Diabetic Foot, Foot Ulcer, Venous Ulcer, Venous Insufficiency, Leg Ulcer.
What interventions are being tested in trial NCT02626156?
The interventions under investigation include: Cooling gel pack (DEVICE), Cooling cotton pack (DEVICE).
Who is sponsoring clinical trial NCT02626156?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02626156 being conducted?
This trial has 2 study locations across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02626156's enrollment target sits among peer trials
140 13th of 30 higher than 18 of 30 other Diabetic Foot trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Foot trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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