Feasibility Study of Cryotherapy for Chronic Venous Disorders (Cryo)
Primary Purpose
Venous Insufficiency
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cyrotherapy as a cool gel wrap
Sponsored by
About this trial
This is an interventional treatment trial for Venous Insufficiency focused on measuring chronic venous disorders, cryotherapy, skin microcirculation, skin temperature
Eligibility Criteria
Inclusion Criteria:
- Aged 45 years and older
- CEAP classification: stage C4 (changes in skin and subcutaneous tissue secondary to CVDs)4a (pigmentation or eczema) 4b (lipodermatosclerosis or atrophie blanche) C5 (healed venous ulcers)
- Ankle brachial index (ABI) 0.9 - 1.3mm Hg 0 absence of peripheral arterial disease
- Intact skin sensation measured with 10 gram monofilament
- Intact thermal sensation measured with thermal sensory tester at lower leg skin and foot surfaces
- Agreement to wear compression garments such as wraps or stockings during waking hours
- Phone, e-mail, or mail accessible
- Working freezer
Exclusion Criteria:
- ABI < 0.8 mm Hg or > 1.3 mm Hg -presence of lower extremity arterial disease (reduces skin temperature)
- Active systemic or localized infections such as cellulitis (raises skin temperature)
- Autoimmune disorders that reduce blood flow such as Raynaud's phenomenon
- Body temperature > 37.6 degrees C (febrile state raises skin temperature)
- CEAP classification c6: active venous ulcer (cooling ulcerated skin might impair healing)
- Known peroneal nerve injury
- Impaired skin sensation
- Unable to detect light touch measured with a 10 gram monofilament at lower leg skin surfaces
- Unable to detect not/cold sensation measured with thermal sensory tester at lower leg skin surfaces
- Not wearing compression or not agreeing to wear compression wraps or stockings
- Phone, e-mail, or mail inaccessible
- No working freezer
Sites / Locations
- Medical University of South Carolina
Outcomes
Primary Outcome Measures
improvement of skin microcirculation
Secondary Outcome Measures
leg pain
quality of life
Full Information
NCT ID
NCT00617825
First Posted
February 6, 2008
Last Updated
June 13, 2018
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT00617825
Brief Title
Feasibility Study of Cryotherapy for Chronic Venous Disorders
Acronym
Cryo
Official Title
Cryotherapy for Chronic Venous Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University of South Carolina
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Severe skin damage caused by chronic venous disorders (CVDs) results in relentless pain and poor quality of life for millions of adults in the U.S. each year. DVDs are under-recognized and under-treated disorders shat harm the veins of the legs and at worst, cause skin inflammation and venous leg ulcers. A new way to ease the pain and inflammation is proposed in this study of cryotherapy (cool gel wraps) applied to damaged skin of the lower legs of CVD-affected individuals. The study hypothesis predicts that this novel cryotherapy model and method will significantly improve the health and quality of life for those with CVDs and that the intervention will become a standard of care for CVDs. In addition, the method will, over time, reduce health care costs associated with treating poor CVD outcomes.
Detailed Description
Chronic venous disorders (CVDs) often cause long-term disability for those who experience the worst manifestations of CVDs: disabling pain and non-healing leg ulcers. Such disabilities have significant socioeconomic implications in terms of lost work days and wages, decreased productivity,and ultimately increased health care costs that deteriorate the well-being and quality of life for those who have CVD-induced illnesses. Because no reliable preventive mechanisms exists for CVDs, this study proposes a preventive, self-management cryotherapy intervention that targets inflamed skin of populations with CVDs at highest risk of developing chronic leg ulcers. The proposed cryotherapy intervention will utilize a randomized controlled clinical trial to develop a method to reduce clinical symptoms by improving existing therapy - it is not a treatment for CVDs itself. In the proposed pilot feasibility study, subjects will be randomized to two groups; the cryotherapy intervention group (n=30) who will receive a four-week, cryotherapy gel wrap applied daily to the affected skin of the lower legs in addition to the standard of care (usual care). The control group (n=30) will receive the usual care of compression wraps or stockings applied to the lower legs and daily leg elevation. With this method, improvement of skin microcirculation, reduced leg pain, and improvement in quality of life will be observed. The following aims will test the hypothesis:
Aim 1: Evaluate the feasibility of the novel intervention including treatment fidelity, subject training, safety, and side effects associated with equipment and recruitment efforts and further refine the intervention protocol, including questionnaires used in our previous studies.
Aim 2: Estimate variability of outcome measurements and effect sizes needed to calculate sample size for a subsequent larger, adequately powered, randomized clinical trial of the efficacy of the novel cryotherapy intervention.
Aim 3: Investigate the presence of a preliminary "signal" of clinical efficacy of the experimental treatment by evaluating trends toward statistical significance for the hypothesis that the experimental group will experience greater reduction in skin temperature and blood flow, greater improvement in pain, and greater improvement in quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Insufficiency
Keywords
chronic venous disorders, cryotherapy, skin microcirculation, skin temperature
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
cyrotherapy as a cool gel wrap
Other Intervention Name(s)
Elastogel Therapy Wrap
Intervention Description
A cool gel wrap made of a hydrogel with silicon will be applied to the lower leg of skin affected by venous disorders for 30 minutes each day for 30 days during the study
Primary Outcome Measure Information:
Title
improvement of skin microcirculation
Time Frame
30 days
Secondary Outcome Measure Information:
Title
leg pain
Time Frame
30 days
Title
quality of life
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 45 years and older
CEAP classification: stage C4 (changes in skin and subcutaneous tissue secondary to CVDs)4a (pigmentation or eczema) 4b (lipodermatosclerosis or atrophie blanche) C5 (healed venous ulcers)
Ankle brachial index (ABI) 0.9 - 1.3mm Hg 0 absence of peripheral arterial disease
Intact skin sensation measured with 10 gram monofilament
Intact thermal sensation measured with thermal sensory tester at lower leg skin and foot surfaces
Agreement to wear compression garments such as wraps or stockings during waking hours
Phone, e-mail, or mail accessible
Working freezer
Exclusion Criteria:
ABI < 0.8 mm Hg or > 1.3 mm Hg -presence of lower extremity arterial disease (reduces skin temperature)
Active systemic or localized infections such as cellulitis (raises skin temperature)
Autoimmune disorders that reduce blood flow such as Raynaud's phenomenon
Body temperature > 37.6 degrees C (febrile state raises skin temperature)
CEAP classification c6: active venous ulcer (cooling ulcerated skin might impair healing)
Known peroneal nerve injury
Impaired skin sensation
Unable to detect light touch measured with a 10 gram monofilament at lower leg skin surfaces
Unable to detect not/cold sensation measured with thermal sensory tester at lower leg skin surfaces
Not wearing compression or not agreeing to wear compression wraps or stockings
Phone, e-mail, or mail inaccessible
No working freezer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teresa J Kelechi, PhD, RN
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425-1600
Country
United States
12. IPD Sharing Statement
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Feasibility Study of Cryotherapy for Chronic Venous Disorders
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