Feasibility Study of Cryotherapy for Chronic Venous Disorders

NCT00617825 | Completed DMC

• 2 other identifiers: 175041R21NR010604-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Insufficiency

Keywords

chronic venous disorders; cryotherapy; skin microcirculation; skin temperature

Outcome Measures

Primary Outcomes (1)

• improvement of skin microcirculation

  30 days

Secondary Outcomes (2)

• leg pain

  30 days

• quality of life

  30 days

Interventions

cyrotherapy as a cool gel wrap OTHER

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

Also known as: Elastogel Therapy Wrap

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425-1600, United States

Location

MeSH Terms

Conditions

Venous Insufficiency

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Teresa J Kelechi, PhD, RN

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 6, 2008
• First Posted: February 18, 2008
• Study Start: September 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: August 1, 2009
• Last Updated: June 15, 2018

Record last verified: 2007-09

Locations

US (1)