Phase 2
N=140
Cooling Leg and Foot Ulcer Skin Post Healing to Prevent Ulcer Recurrence
Venous Hypertension Ulcers · Venous Stasis Ulcer · Venous Ulcer · Venous Insufficiency · Leg Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT02626156 ↗Enrolled (actual)
140
Serious AEs
9.3%
Results posted
Jun 2021
Primary outcome: Primary: Number of Participants With Ulcer Recurrence — 6; 3; 11; 5 participants — p=0.091
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cooling gel pack (Device); Cooling cotton pack (Device)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Ulcer Recurrence |
6; 3; 11; 5 | 0.091 |
| PRIMARY Change in Pain (Worst Pain, Least Pain, Pain Now) |
0.85; 0.4; 0; -1.0; 0.3; 0 | — |
| PRIMARY Differences in Step Counts |
17295; 14234; 13232; 15479 | — |
| PRIMARY Change in Mean Scores on Quality of Life Measured With the VEINES QOL/Sym Questionnaire |
13.8; -4.8; 24.2; -4.3 | — |
| PRIMARY Changes in Severity and Intensity Pain Scores Measured With the Brief Pain Inventory |
-0.5; -0.2; 0; 0.4; -0.4; -0.5 | — |
| PRIMARY Change in METS Minutes Engaging in Physical Activity Measured With The International Physical Activity Questionnaire |
73; 799; 1921; 225 | — |
| PRIMARY Time Spent in Minutes Engaging in Physical Activities |
1420; 2523; 135; 157 | — |
| SECONDARY Participant Adherence to the Study Protocol |
106; 82 | — |
| SECONDARY Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness |
36; 34; 26; 25; 36; 32 | — |
| SECONDARY Knowledge Questionnaire of Study Instructions |
11.7; 11.9; 11.8; 11.9 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT02626156). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.