Cooling Leg and Foot Ulcer Skin Post Healing to Prevent Ulcer Recurrence (MUSTCOOL)
Venous Hypertension Ulcers, Venous Stasis Ulcer, Venous Ulcer
About this trial
This is an interventional treatment trial for Venous Hypertension Ulcers focused on measuring post healed venous leg ulcer, posted healed diabetic foot ulcer
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
- Medical University of South Carolina
- Spartanburg Regional Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Cooling gel pack
Cooling cotton pack
A cooling pack will be applied to affected leg or foot skin where an ulcer has recently healed for 30 minutes three times a week (preventive maintenance). Patients will self monitor skin temperature of affected skin daily to detect elevation and will cool the affected skin daily for 5 consecutive days (bolus) if the skin temperature becomes elevated 2°F above the baseline.
A cooling cotton pack will be applied to affected leg or foot skin where an ulcer has recently healed for 30 minutes three times a week (preventive maintenance). Patients will self monitor skin temperature of affected skin daily to detect elevation and will cool the affected skin daily for 5 consecutive days (bolus) if the skin temperature becomes elevated 2°F above the baseline.