Flexitouch Compression System for Venous Stasis Ulcer

NCT00534937 | Terminated Phase 4 Results DMC

• 1 other identifier: RC-4372
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 2

Brief Summary

The researchers hypothesize that utilization of the Flexitouch system will improve the healing rates of (venous stasis ulcers) VSU compared to traditional compression wrapping therapy alone. Primary Objective: The primary study objective is to determine whether the complete healing rate of venous stasis ulcers at 12 weeks is improved by the addition of Flexitouch® System compression therapy to a standard regimen of compression wrapping. Secondary Objectives:

• To determine whether the addition of Flexitouch System compression therapy to a standard regimen of compression wrapping increases the percentage reduction in wound surface area.
• To determine whether the addition of Flexitouch compression therapy to a standard regimen of compression wrapping increases the percentage reduction in volume of the affected limb.
• To determine whether the addition of Flexitouch compression therapy to a standard regimen of compression wrapping decreases the time to healing of the venous stasis ulcer.

Conditions

Venous Stasis Ulcer

Keywords

Venous stasis ulcer; Compression pump; Randomized trial; Flexitouch compression

Outcome Measures

Primary Outcomes (1)

• Complete Healing Rate of Venous Stasis Ulcers

  Number of subjects that experience complete healing of the study venous stasis ulcer during the 12 week treatment period.

  12 weeks

Secondary Outcomes (3)

• Change in Wound Surface Area for Non Healed Subject at 12 Weeks.

  12 weeks

• Percentage Change in Volume of the Affected Limb (-Reduction; +Increase)

  12 weeks

• Time to Healing of the Venous Stasis Ulcer

  Baseline to 12 weeks

Study Arms (2)

Standard compression

ACTIVE COMPARATOR

Patients in this arm will receive current standard of care (once-weekly short-stretch compression wrapping).

Procedure: Compression wrapping

Flexitouch

EXPERIMENTAL

Patients in this arm will receive once-a-week short stretch compression wrapping AND once-daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).

Procedure: Flexitouch compression pump

Interventions

Compression wrapping PROCEDURE

Short-stretch compression wrap will be applied at least once a week.

Also known as: 3M short-stretch compression wrap

Standard compression

Flexitouch compression pump PROCEDURE

In addition to short-stretch wrapping, this group will received once-daily Flexitouch compression pump, both at home and during the once-a-week clinic visits.

Also known as: 3M compression wrap

Flexitouch

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• This study will enroll patients in a prospective manner with chronic venous insufficiency and venous stasis ulceration as determined from clinical presentation, positive venous reflux testing, or both.
• Patients must be 18 years old or more.
• The VSU size must be in the range 1-64 cm2.
• The ulcer must extend through both the epidermis and dermis, with no exposed tendon or bone.
• The VSU must have been present for more than 1 month.
• The ulcer must be located between and including the knee and ankle.
• The wound bed must have viable tissues with granulation tissue.

You may not qualify if:

• Exposed bone, tendon, or fascia.
• Severe rheumatoid arthritis.
• History of radiotherapy to the ulcer site.
• Uncontrolled congestive heart failure.
• Receiving corticosteroids or immune suppressives.
• History of collagen vascular disease.
• Known malnutrition (albumin \< 2.5 g/dL). If malnutrition is suspected by the principal investigator, the albumin level should be checked to determine whether the patient meets the albumin criterion.
• Ulcer clinically infected at the time of entry into the study. However, patients may be entered into the study after successful treatment of infection.
• Known uncontrolled diabetes (HgbA1c \> 12%). If the principal investigator suspects uncontrolled diabetes, the Hgb A1c should be checked to determine patient eligibility.
• Signs of cellulitis, osteomyelitis, or necrotic or avascular ulcer bed(s).
• Known arterial insufficiency (Ankle-brachial index \< 0.7, or TCPO2 \< 35 mmHg, or Toe brachial index \< 0.4). If the principal investigator suspects uncontrolled diabetes, the Ankle-brachial index should be checked to determine patient eligibility.
• Active sickle cell disease.
• Unable to comply with the procedures described in the protocol.
• Enrolled in a clinical evaluation for another investigational wound-care device or drug.
• Patients diagnosed with deep venous thrombosis or phlebitis in the affected limb in the last 6 months.

Sponsors & Collaborators

• West Penn Allegheny Health System: lead
• The Cleveland Clinic: collaborator
• Tactile Systems Technology, Inc.: collaborator

Study Sites (2)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Allegheny General Hospital Advanced Wound Healing and Lymphedema Center

Pittsburgh, Pennsylvania, 15212, United States

Location

Related Publications (11)

• Palfreyman SJ, Nelson EA, Lochiel R, Michaels JA. Dressings for healing venous leg ulcers. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD001103. doi: 10.1002/14651858.CD001103.pub2.

  PMID: 16855958 BACKGROUND

• Pascarella L, Schonbein GW, Bergan JJ. Microcirculation and venous ulcers: a review. Ann Vasc Surg. 2005 Nov;19(6):921-7. doi: 10.1007/s10016-005-7661-3.

  PMID: 16247708 BACKGROUND

• Black SB. Venous stasis ulcers: a review. Ostomy Wound Manage. 1995 Sep;41(8):20-2, 24-6, 28-30 passim.

  PMID: 7546118 BACKGROUND

• Kramer SA. Compression wraps for venous ulcer healing: a review. J Vasc Nurs. 1999 Dec;17(4):89-97; quiz 98-9. doi: 10.1016/s1062-0303(99)90034-1.

  PMID: 10818887 BACKGROUND

• Hansson C. Optimal treatment of venous (stasis) ulcers in elderly patients. Drugs Aging. 1994 Nov;5(5):323-34. doi: 10.2165/00002512-199405050-00002.

  PMID: 7833586 BACKGROUND

• Mostow EN, Haraway GD, Dalsing M, Hodde JP, King D; OASIS Venus Ulcer Study Group. Effectiveness of an extracellular matrix graft (OASIS Wound Matrix) in the treatment of chronic leg ulcers: a randomized clinical trial. J Vasc Surg. 2005 May;41(5):837-43. doi: 10.1016/j.jvs.2005.01.042.

  PMID: 15886669 BACKGROUND

• O'Donnell TF Jr, Lau J. A systematic review of randomized controlled trials of wound dressings for chronic venous ulcer. J Vasc Surg. 2006 Nov;44(5):1118-25. doi: 10.1016/j.jvs.2006.08.004.

  PMID: 17098555 BACKGROUND

• Falanga V, Sabolinski M. A bilayered living skin construct (APLIGRAF) accelerates complete closure of hard-to-heal venous ulcers. Wound Repair Regen. 1999 Jul-Aug;7(4):201-7. doi: 10.1046/j.1524-475x.1999.00201.x.

  PMID: 10781211 BACKGROUND

• Berliner E, Ozbilgin B, Zarin DA. A systematic review of pneumatic compression for treatment of chronic venous insufficiency and venous ulcers. J Vasc Surg. 2003 Mar;37(3):539-44. doi: 10.1067/mva.2003.103.

  PMID: 12618689 BACKGROUND

• Wollina U, Abdel-Naser MB, Mani R. A review of the microcirculation in skin in patients with chronic venous insufficiency: the problem and the evidence available for therapeutic options. Int J Low Extrem Wounds. 2006 Sep;5(3):169-80. doi: 10.1177/1534734606291870.

  PMID: 16928673 BACKGROUND

• Felty CL, Rooke TW. Compression therapy for chronic venous insufficiency. Semin Vasc Surg. 2005 Mar;18(1):36-40. doi: 10.1053/j.semvascsurg.2004.12.010.

  PMID: 15791552 BACKGROUND

MeSH Terms

Conditions

Varicose Ulcer

Interventions

Compression Bandages

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Bandages; Equipment and Supplies

Limitations and Caveats

The study was terminated early due to lack of enrollment which ultimately lead to a limited number of subjects to include in an analysis.

Results Point of Contact

• Title: Dr. Satish Muluk
• Organization: Allegheny General Hospital

muluk@usa.net

(412) 359-3714

Study Officials

• Satish Muluk, MD

  West Penn Allegheny Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Surgery, Temple University School of Medicine; Associate Professor, Cardiothoracic Surgery, Drexel University College of Medicine

Study Record Dates

• First Submitted: September 24, 2007
• First Posted: September 26, 2007
• Study Start: September 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 1, 2013
• Results First Posted: March 1, 2013

Record last verified: 2013-01

Locations

US (2)