Who is sponsoring NCT02626156?

NCT02626156 is sponsored by Medical University of South Carolina.

What drugs are being tested in NCT02626156?

Interventions in NCT02626156: Cooling gel pack, Cooling cotton pack.

What condition does NCT02626156 study?

NCT02626156 studies Venous Hypertension Ulcers, Venous Stasis Ulcer, Venous Ulcer, Venous Insufficiency, Leg Ulcer, Foot Ulcer, Varicose Ulcer, Diabetic Foot.

Is NCT02626156 still recruiting?

NCT02626156 is currently completed. Last updated 30 June 2021.

Are results published for NCT02626156?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-06-30 · How we verify

NCT02626156: MUSTCOOL

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Results posted Last updated 30 June 2021

What this trial tests

Phase 2 trial testing Cooling gel pack in Venous Hypertension Ulcers in 140 participants. Completed in 31 March 2020.

Timeline

1 June 2015

Primary endpoint
31 March 2020

31 March 2020

Quick facts

Lead sponsor	Medical University of South Carolina
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	140
Start date	1 June 2015
Primary completion	31 March 2020
Estimated completion	31 March 2020
Sites	2 locations across United States

Drugs / interventions tested

Cooling gel pack
Cooling cotton pack

Conditions studied

Venous Hypertension Ulcers — all drugs for Venous Hypertension Ulcers →
Venous Stasis Ulcer — all drugs for Venous Stasis Ulcer →
Venous Ulcer — all drugs for Venous Ulcer →
Venous Insufficiency — all drugs for Venous Insufficiency →

Sponsor

Medical University of South Carolina

Who can join

50 and older, any sex, with Venous Hypertension Ulcers or Venous Stasis Ulcer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Ulcer Recurrence Primary · Through study completion at 6 months from baseline

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.

Group	Value	95% CI
Cooling Gel Pack - Venous Leg Ulcer	6
Cooling Cotton Pack - Venous Leg Ulcer	3
Cooling Gel Pack - Diabetic Foot Ulcer	11
Cotton Cooling Pack - Diabetic Foot Ulcer	5

Change in Pain (Worst Pain, Least Pain, Pain Now) Primary · Through study completion at 6 months from baseline

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

Worst pain

Group	Value	95% CI
Cooling Gel Pack - Venous Leg Ulcer	0.85	-0.1 – 1.6
Cooling Cotton Pack - Venous Leg Ulcer	0.4	-0.6 – 1.3
Cooling Gel Pack - Diabetic Foot Ulcer	0	-1.6 – 1.6
Cooling Cotton Pack - Diabetic Foot Ulcer	-1.0	-2.3 – 0.3

Least pain

Group	Value	95% CI
Cooling Gel Pack - Venous Leg Ulcer	0.3	-0.2 – 0.8
Cooling Cotton Pack - Venous Leg Ulcer	0	-0.6 – 0.6
Cooling Gel Pack - Diabetic Foot Ulcer	-0.1	-0.8 – 0.6
Cooling Cotton Pack - Diabetic Foot Ulcer	0	0 – 0

Pain now

Group	Value	95% CI
Cooling Gel Pack - Venous Leg Ulcer	0.4	-0.06 – 0.9
Cooling Cotton Pack - Venous Leg Ulcer	0.14	-0.3 – 0.5
Cooling Gel Pack - Diabetic Foot Ulcer	0.1	-0.1 – 0.3
Cooling Cotton Pack - Diabetic Foot Ulcer	-0.1	-0.4 – 0.1

Differences in Step Counts Primary · Through study completion at 6 months from baseline

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

Group	Value	95% CI
Cooling Gel Pack - Venous Leg Ulcer	17295	9259 – 25332
Cooling Cotton Pack - Venous Leg Ulcer	14234	6874 – 21593
Cooling Gel Pack - Diabetic Foot Ulcer	13232	2909 – 23555
Cotton Cooling Pack - Diabetic Foot Ulcer	15479	5614 – 25343

Change in Mean Scores on Quality of Life Measured With the VEINES QOL/Sym Questionnaire Primary · Through study completion at 6 months from baseline

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 sco

Quality of life

Group	Value	95% CI
Cooling Gel Pack	13.8	4.0 – 23.5
Cooling Cotton Pack	-4.8	-121.6 – 111.9

Symptoms

Group	Value	95% CI
Cooling Gel Pack	24.2	13.8 – 34.5
Cooling Cotton Pack	-4.3	-7.4 – -1.1

Changes in Severity and Intensity Pain Scores Measured With the Brief Pain Inventory Primary · Through study completion at 6 months from baseline

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

Severity

Group	Value	95% CI
Cooling Gel Pack - Venous Leg Ulcer	-0.5	-1.0 – 0.01
Cooling Cotton Pack - Venous Leg Ulcer	-0.2	-0.8 – 0.4
Cooling Gel Pack - Diabetic Foot Ulcer	0	-0.5 – 0.5
Cotton Cooling Pack - Diabetic Foot Ulcer	0.4	-0.1 – 0.9

Interference

Group	Value	95% CI
Cooling Gel Pack - Venous Leg Ulcer	-0.4	-0.8 – 0.08
Cooling Cotton Pack - Venous Leg Ulcer	-0.5	-1.1 – 0.1
Cooling Gel Pack - Diabetic Foot Ulcer	-0.1	-0.2 – 0.1
Cotton Cooling Pack - Diabetic Foot Ulcer	0.1	-0.2 – 0.3

Change in METS Minutes Engaging in Physical Activity Measured With The International Physical Activity Questionnaire Primary · Through study completion at 6 months from baseline

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 acti

Group	Value	95% CI
Cooling Gel Pack - Venous Leg Ulcer	73	-623 – 767
Cooling Cotton Pack - Venous Leg Ulcer	799	-507 – 2104
Cooling Gel Pack - Diabetic Foot Ulcer	1921	1151 – 4993
Cooling Cotton Pack - Diabetic Foot Ulcer	225	-255 – 705

Time Spent in Minutes Engaging in Physical Activities Primary · Through study completion at 6 months from baseline

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.

Group	Value	95% CI
Cooling Gel Pack - Venous Leg Ulcer	1420	-2448 – 5288
Cooling Cotton Pack - Venous Leg Ulcer	2523	-765 – 5811
Cooling Gel Pack - Diabetic Foot Ulcer	135	28 – 242
Cotton Cooling Pack - Diabetic Foot Ulcer	157	55 – 260

Participant Adherence to the Study Protocol Secondary · Daily measures starting at baseline for temperature and every other day cooling application during the 6-month study period.

Using study data logs, appropriate use of the thermometer and cooling pack was measured by the number of participants who adhered to the protocol for taking the temperature of the skin over the healed venous leg or diabetic foot ulcer. Adherence was defined as: the number of participants who were at least 80% adherent to taking their temperatures with the infrared thermometer each morning and the number of participants who were at least 80% adherent to performing the intervention every other day = 3 times times per week during the 6-month study period.

Temperature

Group	Value	95% CI
Adherence	106

Cooling

Group	Value	95% CI
Adherence	82

Number of Participants Indicating 'Yes' or 'Easy' on Study Instructions, Thermometer Use, Completing Logs, Performing Treatment, Helpfulness Secondary · Survey conducted at end of the 6-month study period.

Patients satisfaction was measured by study personnel a during end of study phone survey with the following questions asked as follows (Yes/No): Were study instructions adequate, was thermometer easy to use, found cooling helpful, would cool skin area if it was proven that cooling prevented reulceration; (Easy/Not Easy): completing logs, performing the cooling treatment. Data are for (Yes/No) as number of participants who reported "yes" or if (Easy/Not Easy) the number of participants who reported "easy."

Study Instructions Adequate - Yes

Group	Value	95% CI
Cooling Gel Pack - Venous Leg Ulcer	36
Cooling Cotton Pack - Venous Leg Ulcer	34
Cooling Gel Pack - Diabetic Foot Ulcer	26
Cotton Cooling Pack - Diabetic Foot Ulcer	25

Using Thermometer Easy - Yes

Group	Value	95% CI
Cooling Gel Pack - Venous Leg Ulcer	36
Cooling Cotton Pack - Venous Leg Ulcer	32
Cooling Gel Pack - Diabetic Foot Ulcer	27
Cotton Cooling Pack - Diabetic Foot Ulcer	25

Completing Logs - Easy

Group	Value	95% CI
Cooling Gel Pack - Venous Leg Ulcer	36
Cooling Cotton Pack - Venous Leg Ulcer	33
Cooling Gel Pack - Diabetic Foot Ulcer	27
Cotton Cooling Pack - Diabetic Foot Ulcer	25

Performing Cooling -Treatment - Easy

Group	Value	95% CI
Cooling Gel Pack - Venous Leg Ulcer	35
Cooling Cotton Pack - Venous Leg Ulcer	31
Cooling Gel Pack - Diabetic Foot Ulcer	26
Cotton Cooling Pack - Diabetic Foot Ulcer	24

Cooling Helpful - Yes

Group	Value	95% CI
Cooling Gel Pack - Venous Leg Ulcer	31
Cooling Cotton Pack - Venous Leg Ulcer	21
Cooling Gel Pack - Diabetic Foot Ulcer	21
Cotton Cooling Pack - Diabetic Foot Ulcer	18

Would Cool if Found to Prevent Re-Ulceration - Yes

Group	Value	95% CI
Cooling Gel Pack - Venous Leg Ulcer	34
Cooling Cotton Pack - Venous Leg Ulcer	33
Cooling Gel Pack - Diabetic Foot Ulcer	24
Cotton Cooling Pack - Diabetic Foot Ulcer	25

Knowledge Questionnaire of Study Instructions Secondary · Baseline after participant enrollment

Participants were administered a 12-item (yes/no) questionnaire (test) during instruction at the start of the study, provided by the research personnel to determine comprehension of the protocol and to reinforce study procedures. Score of 12 or 100% was given for all items scoring correctly (1 point per item). Any items for which "no" was answered, remediation was conducted by study personnel at the time the questionnaire was conducted. Means scores are reported per VLU and DFU cooling pack intervention and VLU and DFU cotton cooling pack control.

Group	Value	95% CI
Cooling Gel Pack - Venous Leg Ulcer	11.7	11 – 12
Cooling Cotton Pack - Venus Leg Ulcer	11.9	11 – 12
Cooling Gel Pack - Diabetic Foot Ulcer	11.8	11 – 12
Cotton Gel Pack - Diabetic Foot Ulcer	11.9	11 – 12

Adverse events — posted to ClinicalTrials.gov

Time frame: Data were collected for each participant for 6 months during study enrollment period.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cooling Gel Pack - Venous Leg Ulcer

Serious: 4/42 (10%)

Deaths: 1/42

Cooling Cotton Pack - Venous Leg Ulcer

Serious: 2/40 (5%)

Deaths: 0/40

Cooling Gel Pack - Diabetic Foot Ulcer

Serious: 3/29 (10%)

Deaths: 0/29

Cooling Cotton Pack - Diabetic Foot Ulcer

Serious: 4/29 (14%)

Deaths: 0/29

Serious adverse events (7 terms)

Reaction	System	Cooling Gel Pack - Venous …	Cooling Cotton Pack - Veno…	Cooling Gel Pack - Diabeti…	Cooling Cotton Pack - Diab…
Heart attack or failure	Cardiac disorders	—	—	—	—
Shortness of breath	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Amputation	Vascular disorders	—	—	—	—
Stroke	Vascular disorders	—	—	—	—
Infection	Infections and infestations	—	—	—	—
Fainted	Ear and labyrinth disorders	—	—	—	—
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—

Other adverse events (6 terms — click to expand)

Reaction	System	Cooling Gel Pack - Venous …	Cooling Cotton Pack - Veno…	Cooling Gel Pack - Diabeti…	Cooling Cotton Pack - Diab…
Recurrent ulcers	Skin and subcutaneous tissue disorders	—	—	—	—
New ulcers	Skin and subcutaneous tissue disorders	—	—	—	—
Surgery	Surgical and medical procedures	—	—	—	—
Injury	Injury, poisoning and procedural complications	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—
Infection	Infections and infestations	—	—	—	—

Most-reported serious reactions: Heart attack or failure, Shortness of breath, Amputation, Stroke, Infection, Fainted, Renal cancer.

Data from ClinicalTrials.gov NCT02626156 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Cooling Intervention (MUSTCOOL) for Prevention of Lower Extremity Ulcer Recurrence: A Randomized Controlled Trial.
Kelechi TJ, Madisetti M, Prentice M, Mueller M. · · 2021 · cited 5× · PMID 33735146 · DOI 10.1097/won.0000000000000753
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.
Kelechi TJ, Mueller M, Madisetti M, Prentice M. · · 2022 · cited 1× · PMID 35507774 · DOI 10.1097/won.0000000000000880

Verify or expand the search:

Other Medical University of South Carolina trials

Trials by the same sponsor.

NCT06491264 — Multiparameter Optimized tES for Memory in Aging · NA · withdrawn
NCT07513389 — Omission of Postoperative Radiation in HPV-Associated Oropharyngeal Cancer Using ctHPVDNA Surveillance (OPERATION) · Phase 2 · not yet recruiting
NCT03101917 — Microtable® Method for Cochlear Implantation Investigational Device Exemption (IDE) · NA · not yet recruiting
NCT07149207 — Intraoperative Molecular Imaging Using ICG for Head and Neck Tumors · Phase 2 · recruiting
NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02626156 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Medical University of South Carolina
Last refreshed: 30 June 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02626156.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing