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MUSC MUSTCOOL: Prevent Ulcer Recurrence

Monitoring and Managing Newly Healed Chronic Leg and Foot Ulcer Skin Temperature: A Cooling Intervention (MUSTCOOL) 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, 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

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

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

Learn More

To learn more, visit ClinicalTrials.Gov

Study Type

Phase II


Medical University of South Carolina