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Cooling Lower Leg Skin to Prevent Venous Leg Ulcers in Patients With Poor Vein Circulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01509599
Recruitment Status : Completed
First Posted : January 13, 2012
Last Update Posted : April 5, 2016
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Teresa Kelechi, Medical University of South Carolina

Brief Summary:
Leg vein circulation problems can damage the skin of the lower legs, especially around the ankles, by making it discolored, hard, itchy, red, and swollen. Ulcers often develop. Inflammation is often present in the damaged skin. This study will test whether using a special low compression, cooling, boot-like gel wrap placed around the damaged skin of the lower legs will improve the skin circulation and prevent leg ulcers. The study hypothesis is: A cryotherapy, low-compression cooling gel wrap (CW) plus usual care (UC) (leg elevation, compression stockings) intervention compared to a low compression non-cryotherapy "sham" wrap (NW) plus UC will reduce tissue blood flow (perfusion units) and decrease the incidence of venous leg ulcers (VLUs) during the 9-month study period in individuals with Stage 4 and 5 venous insufficiency.

Condition or disease Intervention/treatment Phase
Venous Disease Venous Vascular Diseases and Syndromes Venous Insufficiency Venous Ulcers Procedure: Cryotherapy: Cooling gel wrap Procedure: Usual care Phase 1 Phase 2

Detailed Description:
This new trial will assess the efficacy of this home-based cryotherapy intervention by adding sequenced tapered cooling after a 30-day intense cooling period. The goal is to reduce skin blood flow of chronically inflamed skin, decrease the incidence of venous leg ulcers and pain, and improve quality of life. A myriad of surgical, pharmacologic, and non-pharmacologic therapies such as compression bandages are often tried, many with limited success. More than 70% of patients with venous disorders such as insufficiency develop edema, skin damage, and ulcers. Ulcer prevention is warranted because of the significant socioeconomic implications in terms of lost workdays and wages, decreased productivity and increased health care costs. Clinicians focus on the multiple treatment approaches, often without consideration of how patients can contribute to their own self-care. Our 9-month intervention is based on principles of heat transfer and cryotherapy theories involving microcirculation. With input from a cryotherapy expert and participants who completed the R21 pilot, the investigators propose a sequenced intervention strategy, where cooling will be dosed daily for 30 minutes for the first month, and then decreased to twice weekly dosing in months 2-3, once weekly in months 4-6, then PRN in months 7-9. The investigators will measure blood flow, skin temperature, pain, quality of life, and the incidence of leg ulcers after months 1, 3, 6 and 9. Eligible participants will be randomized to treatment (low compression cooling wrap) or usual care (low compression non-cooling "sham" wrap). Participants in both groups will receive all study related materials including standardized instruction, skin thermometer, specially designed low compression wraps, leg elevator pillow, and compression stockings, and during an in-depth orientation session. The investigators hypothesize that cryotherapy will enhance the largely ineffective non-pharmacologic self-care usual care model, that is, telling patients to wear compression stockings, elevate the legs, and get more exercise. These strategies are generally inadequate in achieving sustained change. Among our research methods the investigators include rigorous process, impact and outcome monitoring. In an era of expectation for technological and pharmaceutical "fixes", this self-care strategy, if efficacious, could be an economical way to decrease morbidity and pain for thousands of patients, frequently viewed as non-responsive to self care. Prevention of ulcers is also a major potential source of saved medical dollars. This trial is significant due to the burden of venous disorders, the complex physical characteristics of the population including excessive obesity and co-morbidity and the need to reach patients with a feasible, motivational, and supportive strategy to promote self-care. The objective is to establish a new practice standard for prevention.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Preventing Venous Leg Ulcers With Cryotherapy: A Randomized Clinical Trial
Study Start Date : August 2011
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Cryotherapy
Cryotherapy is delivered via a cooling "gel" wrap applied to the affected lower leg using a dosing regimen, starting with daily cooling in month one to PRN in the last 3 months over the 9 month study.
Procedure: Cryotherapy: Cooling gel wrap
Patients will wear compression stockings (provided), elevate legs on an elevator pillow (provided) and apply the sham cyrotherapy: cooling gel wrap during the home-based intervention
Other Name: Cooling cuff, cool cuff

Sham Comparator: Usual care
The "sham" wrap, filled with cotton, is applied to the affected lower leg using a dosing regimen, starting with daily application in month one to PRN in the last 3 months over the 9 month study.
Procedure: Usual care
Patients will wear compression stockings (provided), elevate legs on an elevator pillow (provided) and apply the sham cyrotherapy wrap (sham) during the home-based intervention
Other Names:
  • Standard of care
  • Guideline guided care

Primary Outcome Measures :
  1. Skin blood flow [ Time Frame: Skin blood flow will be measured for change at five visits: baseline (visit 1), month 1 (visit 2), month 3 (visit 3), month 6 (visit 4) and 9 (visit 5) ]
  2. Incidence of venous leg ulcers that develop during the study [ Time Frame: Time point will be assessed at months 1, 3, 6 and 9. If an ulcer develops, participants will be followed weekly, for the duration of the ulcer treatment, up to the end of the study at 9 months. ]
    In the event that a venous leg ulcers develops, the volunteer will notify the study personnel within 24 hours. The volunteer will be instructed to return to the primary care/wound care provider for treatment. Study personnel will contact the volunteer each week to assess progress. If the leg ulcers heals during the time enrolled in the study, the volunteer will continue with the intervention.

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: During the five measurement points, baseline and then after months, 1, 3, 6, and 9 ]
  2. Pain [ Time Frame: Measured at baseline, then after months 1, 3, 6, and 9 ]
  3. Skin temperature [ Time Frame: Will be measured daily by the subject and then by student personnel at baseline, then after months 1, 3, 6, and 9 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • aged 21 years or older
  • CEAP Classification: Stage C4 (skin damage) and 5 (healed VLU) - leg ulcer healed within past month with intact epithelium
  • history of healed VLU within past 2 years
  • ankle brachial index (ABI) 0.80 - 1.3 mmHG, absence of peripheral arterial disease
  • intact skin sensation
  • intact thermal sensation
  • agreement to ear compression during waking hours
  • phone, email or mail accessible
  • willingness to make 5 study visits including baseline
  • able to understand protocol by passing test after watching DVD standardized instructions for low literacy
  • able to perform required protocol activities
  • ability to speak English

Exclusion Criteria:

  • diagnosed arterial disease or ABI <0.80 or >1.3 mm Hg (blood flow to the skin is reduced in arterial disease and cooling could cause tissue ischemia)
  • surgical procedures on leg in past 1 year (can affect venous circulation/cause edema)
  • open leg/foot ulcers
  • recent leg infection within past month (increased inflammation)
  • impaired cognitive status (cannot perform procedures)
  • chronic inflammatory and vascular conditions where blood flow of the skin may be impacted such as Lupus erythematosus, lymphedema, Raynaud's, rheumatoid arthritis, scleroderma, end stage renal disease, chronic obstructive pulmonary disease, chronic regional pain syndrome, multiple sclerosis, hypersensitivity to cold, or patients on chemotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01509599

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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
Sponsors and Collaborators
Medical University of South Carolina
National Institute of Nursing Research (NINR)

Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Teresa Kelechi, Associate Professor and Department Chair, Medical University of South Carolina Identifier: NCT01509599    
Other Study ID Numbers: Pro00008711
1R01NR012237-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 13, 2012    Key Record Dates
Last Update Posted: April 5, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data may be requested via the PI and is available through REDCap.
Keywords provided by Teresa Kelechi, Medical University of South Carolina:
Venous disease
Venous disorders
Venous insufficiency
Venous ulcers
Additional relevant MeSH terms:
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Vascular Diseases
Varicose Ulcer
Venous Insufficiency
Leg Ulcer
Pathologic Processes
Cardiovascular Diseases
Skin Ulcer
Skin Diseases
Varicose Veins
Methyl salicylate
Antirheumatic Agents