Cooling Leg and Foot Ulcer Skin Post Healing to Prevent Ulcer Recurrence

NCT02626156 | Completed Phase 2 Results DMC

• 1 other identifier: Pro00043450
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Venous Hypertension Ulcers; Venous Stasis Ulcer; Venous Ulcer; Venous Insufficiency; Leg Ulcer; Foot Ulcer; Varicose Ulcer; Diabetic Foot

Keywords

post healed venous leg ulcer; posted healed diabetic foot ulcer

Outcome Measures

Primary Outcomes (7)

• Number of Participants With Ulcer Recurrence

  Number of recurrent ulcers that develop during the 6 month study period for in participants for 4 groups of patients with previously healed venous leg ulcers receiving the cooling gel pack and cooling cotton pack and those with previously healed diabetic foot ulcers receiving the cooling gel pack or cooling cotton pack.

  Through study completion at 6 months from baseline

• Change in Pain (Worst Pain, Least Pain, Pain Now)

  Pain was measured with a visual analog scale and reported numerically (0 to 10 with 10 being the most severe pain) at baseline and at 6 months end of study

  Through study completion at 6 months from baseline

• Differences in Step Counts

  Differences in step counts reported via accelerometer data, from baseline to post treatment at 6 months end of intervention for the 4 groups.

  Through study completion at 6 months from baseline

• Change in Mean Scores on Quality of Life Measured With the VEINES QOL/Sym Questionnaire

  The Venous Insufficiency Epidemiological and Economic Study-Quality of life/Symptoms (VEINES QOL/Sym) Questionnaire was used to evaluate quality of life. A sum score is provided as an overall quality of life score for both the QOL and Sym portions of the questionnaire. This instrument was used only for the VLU groups because it is a disease-specific measure. Of the 26 items in the questionnaire, 25 items are combined to create a summary score (VEINES-QOL). One item which asks about the time of day the leg problem is most intense, question 2, provides only descriptive information and is not scored. A subset (symptoms score) of ten of these items, questions 1a to 1i and 7, is used to create a symptom score (VEINES-Sym). For both the VEINES-QOL and VEINES-Sym scores, high values indicate better outcomes. VEINES-QOL scores can be compared only to other members of the same sample. Each set of VEINES-QOL scores will have a mean T-score = 50.

  Through study completion at 6 months from baseline

• Changes in Severity and Intensity Pain Scores Measured With the Brief Pain Inventory

  The Brief Pain Inventory (BPI) scale is reported as an average score. BPI rapidly assesses the severity of pain and its impact on functioning for intensity and Pain Intensity and Pain Interference. Pain Intensity is measured in four categories: worst, least, on average, and currently, while Pain Interference is measured in 7 categories: mood, work, general activity, walking, relationships, enjoyment of life, and sleep. The patient rates each of these on a scale from 0-10, 10 being excruciating pain intensity and a complete interference in their life. Subscores are determined by averaging over the 4 intensity items for the severity subscore and over the 7 interference items for the interference subscore; possible total scores range from 0 to 10. Higher scores indicate worse intensity and severity.

  Through study completion at 6 months from baseline

• Change in METS Minutes Engaging in Physical Activity Measured With The International Physical Activity Questionnaire

  Change in metabolic equivalent of task (METS) min per week for physical activity per The International Physical Activity Questionnaire reported for 4 groups from baseline to 6 months end of study. Scoring HIGH indicate physical activity levels equate to \~1hour of activity per day or more at least moderate intensity level or engage in vigorous intensity activity on at least 3 days achieving a minimum total physical activity of at least 1500 MET min a week or 7 or more days of any combination of walking, moderate intensity or vigorous intensity activities achieving a minimum total physical activity of at least 3000 MET min a week. MODERATE suggests engagement equivalent to 30 min of at least moderate intensity activity on most days; engage in 3 or more days of vigorous intensity activity and/or walking of at least 30 min per day or 5 or more days of moderate intensity activity and/or walking of at least 30 minutes per day. LOW level means that neither MODERATE or HIGH levels are met.

  Through study completion at 6 months from baseline

• Time Spent in Minutes Engaging in Physical Activities

  Mean time spent in minutes engaging in physical activities, reported via accelerometer data, from baseline to post treatment at 6 months end of intervention for the 4 groups.

  Through study completion at 6 months from baseline

Secondary Outcomes (3)

• Participant Adherence to the Study Protocol

  Daily measures starting at baseline for temperature and every other day cooling application during the 6-month study period.

• Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness

  Survey conducted at end of the 6-month study period.

• Knowledge Questionnaire of Study Instructions

  Baseline after participant enrollment

Study Arms (2)

Cooling gel pack

EXPERIMENTAL

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.

Device: Cooling gel pack

Cooling cotton pack

ACTIVE COMPARATOR

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.

Device: Cooling cotton pack

Interventions

Cooling gel pack DEVICE

Individuals will self monitor skin temperature of skin over a recently health venous leg or diabetic foot ulcer with a dermal thermometer. A cooling gel pack will be applied to skin of recently healed venous leg or diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increases and stays elevated 2°F above the usual temperature of that site, the individual will cool the skin 5 consecutive days and will continue to monitor skin temperature.

Cooling gel pack

Cooling cotton pack DEVICE

Individuals will self monitor skin temperature of skin over a recently health venous leg or diabetic foot ulcer with a dermal thermometer. A cotton filled pack will be applied to skin of recently healed venous leg or diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increases and stays elevated 2°F above the usual temperature of that site, the individual will cool the skin 5 consecutive days and will continue to monitor skin temperature.

Cooling cotton pack

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (2)

Medical University of South Carolina

Charleston, South Carolina, 29412, United States

Location

Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Related Publications (2)

• Kelechi TJ, Mueller M, Madisetti M, Prentice M. Efficacy of a Self-managed Cooling Intervention for Pain and Physical Activity in Individuals With Recently Healed Chronic Venous Leg and Diabetic Foot Ulcers: A Randomized Controlled Trial. J Wound Ostomy Continence Nurs. 2022 Jul-Aug 01;49(4):365-372. doi: 10.1097/WON.0000000000000880. Epub 2022 May 4.

  PMID: 35507774 DERIVED

• Kelechi TJ, Madisetti M, Prentice M, Mueller M. Cooling Intervention (MUSTCOOL) for Prevention of Lower Extremity Ulcer Recurrence: A Randomized Controlled Trial. J Wound Ostomy Continence Nurs. 2021 May-Jun 01;48(3):203-210. doi: 10.1097/WON.0000000000000753.

  PMID: 33735146 DERIVED

MeSH Terms

Conditions

Varicose Ulcer; Venous Insufficiency; Leg Ulcer; Foot Ulcer; Diabetic Foot

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Foot Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Results Point of Contact

• Title: Teresa J. Kelechi
• Organization: Medical University of South Carolina

kelechtj@musc.edu

843-792-4602

Study Officials

• Moby Madisetti, MS

  Medical University of South Carolina

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 10, 2015
• Study Start: June 1, 2015
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: June 30, 2021
• Results First Posted: June 29, 2021

Record last verified: 2021-06

Locations

US (2)