Cooling Leg and Foot Ulcer Skin Post Healing to Prevent Ulcer Recurrence (NCT02626156) | Clinical Trial Compass
CompletedPhase 2
Cooling Leg and Foot Ulcer Skin Post Healing to Prevent Ulcer Recurrence
United States140 participantsStarted 2015-06-01
Plain-language 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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Ulcer Recurrence
Timeframe: Through study completion at 6 months from baseline
2
Change in Pain (Worst Pain, Least Pain, Pain Now)
Timeframe: Through study completion at 6 months from baseline
3
Differences in Step Counts
Timeframe: Through study completion at 6 months from baseline
4
Change in Mean Scores on Quality of Life Measured With the VEINES QOL/Sym Questionnaire
Timeframe: Through study completion at 6 months from baseline
5
Changes in Severity and Intensity Pain Scores Measured With the Brief Pain Inventory
Timeframe: Through study completion at 6 months from baseline
6
Change in METS Minutes Engaging in Physical Activity Measured With The International Physical Activity Questionnaire
Timeframe: Through study completion at 6 months from baseline
7
Time Spent in Minutes Engaging in Physical Activities