Venous Hypertension UlcersPhase 2MUSTCOOLNCT02626156
Cooling Leg and Foot Ulcer Skin Post Healing to Prevent Ulcer Recurrence
A Phase 2 study testing Cooling gel pack and Cooling cotton pack in people with Venous Hypertension Ulcers and Venous Stasis Ulcer, run by Medical University of South Carolina at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Venous Hypertension Ulcers, Venous Stasis Ulcer, Venous Ulcer
- What is being tested?
- Cooling gel pack and Cooling cotton pack
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2015to 31 Mar 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical University of South Carolina
Charleston, South Carolina, 29412
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303
About this study
Official title: Monitoring and Managing Newly Healed Chronic Leg and Foot Ulcer Skin Temperature: A Cooling Intervention (MUSTCOOL) to Prevent Ulcer Recurrence
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.
Read the detailed description
The goal of this randomized control trial is to test a patient directed self-monitoring and self-management intervention aimed at preventing the recurrence of chronic venous leg and diabetic foot ulcers using skin temperature and cryotherapy (cooling). This MUSTCOOL study is a novel ulcer prevention strategy for patients at highest risk for developing chronic ulcers; those with a previous history. The aims are to compare a cooling treatment to a placebo to determine the outcomes on ulcer recurrence, pain, physical activity and quality of life.
Individuals with newly healed chronic ulcers will be invited to participate in MUSTCOOL's two component intervention:
- self monitoring skin temperature over targeted "hot spots" daily with an infrared thermometer; and
- maintenance cooling with a cooling pack (or placebo pack) placed over the "hot spot" three times each week for 30 minutes. If the temperature of the "hot spot" becomes elevated 2°F above baseline (average of 30 days of daily temperature readings) for 2 days in a row, a bolus regimen of 5 consecutive daily, 30 minute applications of the cooling or placebo pack will be implemented. The safety and side effects will be monitored, however, there have been no reported adverse events reported in our previous cryotherapy studies.
This study was designed as a chronic ulcer prevention intervention that targets the remodeling phase, the final repair process of healing after chronic ulcer closure. The skin environment is particularly vulnerable to ulcer recurrence due to a persistent aberrant inflammatory state. The previous research conducted by the study team has demonstrated that cooling this skin reduces the abnormal metabolic activity, protecting it against ulcer recurrence. Recent advancements in infrared technology allow us to take images of the affect skin to identify the area that has the highest temperature or vulnerable "hot spot". These "hot spots" will be self monitored by patients with newly healed ulcers in the home with an infrared thermometer that date and time stamps each reading. The study's outcomes on physical activity will be evaluated with an accelerometer. It is hypothesized that by improving the skin environment and reducing pain, patients will more likely be physically active and have better quality of life, all measurable goals for this study.
This prevention strategy will be evaluated over six months in 180 patients, 90 of whom will be randomized to receive the cooling pack and 90 the placebo. The goal is to test this non-pharmacological, non-invasive clinical intervention as a tailored self-management strategy to prevent chronic ulcer recurrence. It will also determine alleviation of symptoms such as pain, and the debilitating effects on physical activity and quality of life.
- Conditions
- Venous Hypertension Ulcers, Venous Stasis Ulcer, Venous Ulcer, Venous Insufficiency, Leg Ulcer, Foot Ulcer
- Being tested
- Cooling gel pack, Cooling cotton pack
- Keywords
- post healed venous leg ulcer, posted healed diabetic foot ulcer
- Medical subject headings
- Varicose Ulcer, Venous Insufficiency, Leg Ulcer, Foot Ulcer, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooling gel packDevice
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 cotton packDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Cooling cotton pack |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion at 6 months from baseline
Secondary outcomes (3)
Participant Adherence to the Study Protocol
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.
Measured: 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
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."
Measured: Survey conducted at end of the 6-month study period.
Knowledge Questionnaire of Study Instructions
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.
Measured: Baseline after participant enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2015 (estimated)
- Study start1 Jun 2015
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Venous Hypertension UlcersStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Moby Madisetti, MS, Study director, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02626156
- Sponsor's protocol ID
- Pro00043450
- Acronym
- MUSTCOOL
- Status last verified
- Jun 2021
- First submitted
- 1 Dec 2015
- Last updated
- 30 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Kelechi TJ, Prentice M, Mueller M, Madisetti M. Infrared Thermometry and Thermography in Detecting Skin Temperature Variations to Predict Venous Leg Ulcer Reulceration: A Case Report. J Wound Ostomy Continence Nurs. 2024 Sep-Oct 01;51(5):405-414. doi: 10.1097/WON.0000000000001114. Epub 2024 Sep 21.
PubMed 39313976Kelechi 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.
PubMed 35507774Kelechi 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.
PubMed 33735146
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring and Managing Newly Healed Chronic Leg and Foot Ulcer Skin Temperature: A Cooling Intervention (MUSTCOOL) to Prevent Ulcer Recurrence
- ClinicalTrials.gov ID
- NCT02626156
- Acronym / sponsor ID
- MUSTCOOL / Pro00043450
- Conditions
- Venous Hypertension Ulcers, Venous Stasis Ulcer, Venous Ulcer, Venous Insufficiency, Leg Ulcer, Foot Ulcer
- Keywords
- post healed venous leg ulcer, posted healed diabetic foot ulcer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 10 Dec 2015 (estimated)
- Results
- Posted 29 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The goal of this randomized control trial is to test a patient directed self-monitoring and self-management intervention aimed at preventing the recurrence of chronic venous leg and diabetic foot ulcers using skin temperature and cryotherapy (cooling). This MUSTCOOL study is a novel ulcer prevention strategy for patients at highest risk for developing chronic ulcers; those with a previous history. The aims are to compare a cooling treatment to a placebo to determine the outcomes on ulcer recurrence, pain, physical activity and quality of life.
Individuals with newly healed chronic ulcers will be invited to participate in MUSTCOOL's two component intervention:
- self monitoring skin temperature over targeted "hot spots" daily with an infrared thermometer; and
- maintenance cooling with a cooling pack (or placebo pack) placed over the "hot spot" three times each week for 30 minutes. If the temperature of the "hot spot" becomes elevated 2°F above baseline (average of 30 days of daily temperature readings) for 2 days in a row, a bolus regimen of 5 consecutive daily, 30 minute applications of the cooling or placebo pack will be implemented. The safety and side effects will be monitored, however, there have been no reported adverse events reported in our previous cryotherapy studies.
This study was designed as a chronic ulcer prevention intervention that targets the remodeling phase, the final repair process of healing after chronic ulcer closure. The skin environment is particularly vulnerable to ulcer recurrence due to a persistent aberrant inflammatory state. The previous research conducted by the study team has demonstrated that cooling this skin reduces the abnormal metabolic activity, protecting it against ulcer recurrence. Recent advancements in infrared technology allow us to take images of the affect skin to identify the area that has the highest temperature or vulnerable "hot spot". These "hot spots" will be self monitored by patients with newly healed ulcers in the home with an infrared thermometer that date and time stamps each reading. The study's outcomes on physical activity will be evaluated with an accelerometer. It is hypothesized that by improving the skin environment and reducing pain, patients will more likely be physically active and have better quality of life, all measurable goals for this study.
This prevention strategy will be evaluated over six months in 180 patients, 90 of whom will be randomized to receive the cooling pack and 90 the placebo. The goal is to test this non-pharmacological, non-invasive clinical intervention as a tailored self-management strategy to prevent chronic ulcer recurrence. It will also determine alleviation of symptoms such as pain, and the debilitating effects on physical activity and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cooling gel pack | Experimental | Device: Cooling gel packA 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. |
| Cooling cotton pack | Active comparator | Device: Cooling cotton packA 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cooling gel packIndividuals 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. | Device | Cooling gel pack |
| Cooling cotton packIndividuals 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. | Device | Cooling cotton pack |
Primary outcome
Number of Participants With Ulcer Recurrence
Time frame: 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.
Change in Pain (Worst Pain, Least Pain, Pain Now)
Time frame: 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
Differences in Step Counts
Time frame: 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.
Change in Mean Scores on Quality of Life Measured With the VEINES QOL/Sym Questionnaire
Time frame: 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 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.
Changes in Severity and Intensity Pain Scores Measured With the Brief Pain Inventory
Time frame: 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 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.
Change in METS Minutes Engaging in Physical Activity Measured With The International Physical Activity Questionnaire
Time frame: 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 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.
Time Spent in Minutes Engaging in Physical Activities
Time frame: 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.
3 secondary outcomes
Participant Adherence to the Study Protocol
Time frame: 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
Time frame: Survey conducted at end of the 6-month study period.
Knowledge Questionnaire of Study Instructions
Time frame: Baseline after participant enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39313976Kelechi TJ, Prentice M, Mueller M, Madisetti M. Infrared Thermometry and Thermography in Detecting Skin Temperature Variations to Predict Venous Leg Ulcer Reulceration: A Case Report. J Wound Ostomy Continence Nurs. 2024 Sep-Oct 01;51(5):405-414. doi: 10.1097/WON.0000000000001114. Epub 2024 Sep 21.
- Derived from this study: PubMed 35507774Kelechi 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.
- Derived from this study: PubMed 33735146Kelechi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moby Madisetti, MS study director
Medical University of South Carolina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cooling gel pack and Cooling cotton pack in people with Venous Hypertension Ulcers and Venous Stasis Ulcer, run by Medical University of South Carolina at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Ulcer Recurrence (time frame: Through study completion at 6 months from baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02626156, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021.