Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02626156
The ClinicalTrials.gov registry entry for NCT02626156 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 10,337-participant average among 30 other Diabetic Foot trials with a reported enrollment target (99% lower). The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 1 distinct geographic area - top geographies include 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
Similar trials for Diabetic Foot
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Safety and Efficacy Study of DSC127 in Treating Subjects With Diabetic Ulcers
COMPLETED · Phase 2
-
Feasibility and Effectiveness of a Remote Monitoring Program for the Treatment of Diabetic Foot Ulcers
RECRUITING · NA
-
DFC 004 Biomarkers for Active Diabetic Foot Ulcers
RECRUITING
-
Effectiveness of Remote Foot Temperature Monitoring
RECRUITING · NA
-
A Real-World Registry of Chronic Wounds and Ulcers
RECRUITING
-
Modified Platform Trial Evaluating PpLHACM and SOC Versus SOC Alone in the Treatment of Nonhealing DFUs
RECRUITING · NA
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.