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

NCT01509599 | Completed Phase 1 DMC

• 2 other identifiers: Pro000087111R01NR012237-01A1
• Study Type: interventional
• Target: 197
• Locations: 1 country
• Sites: 2

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.

Conditions

Venous Disease; Venous Vascular Diseases and Syndromes; Venous Insufficiency; Venous Ulcers

Keywords

Venous disease; Venous disorders; Venous insufficiency; Venous ulcers; Cryotherapy

Outcome Measures

Primary Outcomes (2)

• Skin blood flow

  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)

• Incidence of venous leg ulcers that develop during the study

  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.

  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.

Secondary Outcomes (3)

• Quality of life

  During the five measurement points, baseline and then after months, 1, 3, 6, and 9

• Pain

  Measured at baseline, then after months 1, 3, 6, and 9

• Skin temperature

  Will be measured daily by the subject and then by student personnel at baseline, then after months 1, 3, 6, and 9

Study Arms (2)

Cryotherapy

EXPERIMENTAL

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

Usual care

SHAM COMPARATOR

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

Interventions

Cryotherapy: Cooling gel wrap PROCEDURE

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

Also known as: Cooling cuff, cool cuff

Cryotherapy

Usual care PROCEDURE

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

Also known as: Standard of care, Guideline guided care

Usual care

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (2)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Related Publications (5)

• Kelechi TJ, Johnson JJ, Yates S. Chronic venous disease and venous leg ulcers: An evidence-based update. J Vasc Nurs. 2015 Jun;33(2):36-46. doi: 10.1016/j.jvn.2015.01.003.

  PMID: 26025146 BACKGROUND

• Kelechi TJ, Madisetti M, Mueller M, Dooley M, Prentice M. Self-monitoring of lower leg skin temperature: accuracy of self-reported data and adherence to a cooling protocol for the prevention of venous leg ulcers. Patient Prefer Adherence. 2015 Dec 15;9:1751-61. doi: 10.2147/PPA.S91992. eCollection 2015.

  PMID: 26719678 RESULT

• Kelechi TJ, Mueller M, King DE, Madisetti M, Prentice M. Impact of daily cooling treatment on skin inflammation in patients with chronic venous disease. J Tissue Viability. 2015 May;24(2):71-9. doi: 10.1016/j.jtv.2015.01.006. Epub 2015 Feb 7.

  PMID: 25703058 RESULT

• Kelechi TJ, Mueller M, Dooley M. Sex differences in symptom severity and clusters in patients with stage C4 and stage C5 chronic venous disease. Eur J Cardiovasc Nurs. 2017 Jan;16(1):28-36. doi: 10.1177/1474515116634526. Epub 2016 Jul 7.

  PMID: 26888961 RESULT

• Monsen KA, Kelechi TJ, McRae ME, Mathiason MA, Martin KS. Nursing Theory, Terminology, and Big Data: Data-Driven Discovery of Novel Patterns in Archival Randomized Clinical Trial Data. Nurs Res. 2018 Mar/Apr;67(2):122-132. doi: 10.1097/NNR.0000000000000269.

  PMID: 29489633 DERIVED

MeSH Terms

Conditions

Syndrome; Venous Insufficiency; Varicose Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Varicose Veins; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor and Department Chair

Study Record Dates

• First Submitted: August 19, 2011
• First Posted: January 13, 2012
• Study Start: August 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 5, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will share

Locations

US (2)