Cooling Leg and Foot Ulcer Skin Post Healing to Prevent Ulcer Recurrence
Completed · Phase 2
Conditions studied: Venous Hypertension Ulcers, Venous Stasis Ulcer, Venous Ulcer, Venous Insufficiency, Leg Ulcer, Foot Ulcer, Varicose Ulcer, Diabetic Foot
In brief
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.
Key facts
- Study ID
- NCT02626156
- Run by
- Medical University of South Carolina
- People needed
- 140
- Starts
- 2015-06-01
- Expected to finish
- 2020-03-31
- Last updated by the study team
- 2021-06-30
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Newly healed leg or diabetic foot ulcer within past 7 - 14 days
- Ankle brachial index 0.8- 1.3mmHg (rule out absence of arterial disease)
- Willing to wear compression stockings and appropriate footwear
- Working freezer
You may not qualify if…
- Open leg or foot ulcers
- Cognitive impairment: unable to recall 2 or more words or draw clock Mini-Cog™ for cognitive impairment
- Chronic inflammatory or vascular conditions where blood flow of skin may be impaired such as Lupus erythematosus, Raynaud's, scleroderma, end stage renal disease, chronic regional pain syndrome, multiple sclerosis, hypersensitivity to cold, on chemotherapy
- Unable to preform required protocol activities without assistance (return demonstration to study staff)
Where it is running
- Medical University of South Carolina — Charleston, South Carolina, United States
- Spartanburg Regional Medical Center — Spartanburg, South Carolina, United States
Full record on ClinicalTrials.gov
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