Monitoring and Managing Newly Healed Chronic Leg and Foot Ulcer Skin Temperature: A Cooling Intervention (MUSTCOOL) to Prevent Ulcer Recurrence
Overview
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 Inclusion Criteria
For a patient to be eligible for participation in this study, all of the following criteria must apply.
- 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
Key Exclusion Criteria
A patient will not be eligible for participation in this study if any of the following criteria apply.
- 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 perform required protocol activities without assistance (return demonstration to study staff)
Learn More
To learn more, visit ClinicalTrials.Gov
Study Type
Phase II
Sponsor(s)
Medical University of South Carolina