Feasibility Study of Cryotherapy for Chronic Venous Disorders - Full Text View

Sponsored by:	Medical University of South Carolina
Information provided by:	Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT00617825

Purpose

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.

Condition	Intervention
Venous Insufficiency	Other: cyrotherapy as a cool gel wrap

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Cryotherapy for Chronic Venous Disorders

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:

improvement of skin microcirculation [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

leg pain [ Time Frame: 30 days ] [ Designated as safety issue: No ]
quality of life [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	September 2007
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

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.

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617825

Contacts

Contact: Teresa J Kelechi, PhD, RN	843-792-4602	kelechtj@musc.edu
Contact: Janice Wiseman, RN	843-460-0681	jan-wiseman@hotmail.com

Locations

United States, South Carolina
Medical University of South Carolina	Recruiting
Charleston, South Carolina, United States, 29425-1600
Contact: Teresa J Kelechi, PhD, RN 843-792-4602 kelechtj@musc.edu
Principal Investigator: Teresa J Kelechi, PhD, RN

Sponsors and Collaborators

Medical University of South Carolina

Investigators

Principal Investigator:

Teresa J Kelechi, PhD, RN

Medical University of South Carolina

More Information

No publications provided

Responsible Party:	Medical University of South Carolina ( Teresa J. Kelechi, PhD, RN )
Study ID Numbers:	17504, 1R21 NR010604-01
Study First Received:	February 6, 2008
Last Updated:	February 15, 2008
ClinicalTrials.gov Identifier:	NCT00617825 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:

chronic venous disorders
cryotherapy
skin microcirculation
skin temperature

Study placed in the following topic categories:

Silicon
Venous Insufficiency
Vascular Diseases

Additional relevant MeSH terms:

Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 10, 2009