Flexitouch Treatment for Venous Ulcers

NCT00847002 | Terminated Results FDA Device

• 1 other identifier: FWFT07312007
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

This is a study to compare the healing process of venous stasis ulcers when the Flexitouch® system is added to the standard treatment of venous ulcers. We hypothesize that adding the Flexitouch® system to standard venous ulcer treatment will result in

1. 1.greater complete healing
2. 2.greater percentage reduction in ulcer area
3. 3.reduced time to complete healing, as compared to the use of standard treatment alone
4. 4.a greater reduction in affected leg volume as compared to standard treatment alone.

Conditions

Venous Ulcer

Keywords

Flexitouch system; FarrowWrap; venous stasis ulcer

Outcome Measures

Primary Outcomes (1)

• Wound Healing

  12 weeks

Secondary Outcomes (1)

• Reduction in Leg Volume

  12 weeks

Study Arms (2)

Standard Wound Care

ACTIVE COMPARATOR

Gentle wound ulcer cleansing with saline solution at each visit, maintaining moisture balance in the wound and periwound with appropriate dressings (e.g Acticoat, Aquacel Ag, or Mepilex Ag foam dressings), reminding subjects of importance of proper nutrition, leg elevation at rest and activity, including frequent ambulation and ankle range of motion exercises through the day. The FarrowWrap Classic device is applied over the dressing to achieve suitable compression pressures as an important component of the standard treatment.

Device: Standard Wound Care

Flexitouch system with Standard Wound Care

ACTIVE COMPARATOR

In addition to standard wound care, patients who have been randomized to this group will be provided a home Flexitouch unit. They will be given instructions to use it on a twice daily basis (FarrowWrap will be removed during the time they are using Flexitouch). The Flexitouch System works by applying dynamic low-pressure compression to the trunk and affected limbs using gentle, rhythmic massage action.

Device: Flexitouch System with Standard Wound Care

Interventions

Standard Wound Care DEVICE

Also known as: Farrow Wrap, Acticoat, Aquacel Ag, or Mepilex Ag foam dressings

Standard Wound Care

Flexitouch System with Standard Wound Care DEVICE

Also known as: Flexitouch system, Farrow Wrap, Acticoat, Aquacel Ag, or Mepilex Ag foam dressings

Flexitouch system with Standard Wound Care

Eligibility Criteria

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

You may qualify if:

• Patient must be at least 18 years old
• The ulcer maximum length x its maximum width must be greater or equal to 0 cm2
• The ulcer must extend through both the epidermis and dermis, with no exposed tendon or bone.
• The ulcer must have been present for more than 1 month.
• The ulcer must be located below the knee.
• The ulcer bed must have some viable tissues with some 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 suppressive therapy
• History of collagen vascular disease
• Known malnutrition (albumin\<3.0 g/dL). If malnutrition is suspected, the albumin level should be checked to determine if the patient meets the albumin criterion.
• The ulcer is clinically infected. However, patients may be entered into the study after successful treatment of infection.
• Known uncontrolled diabetes (HgbA1c \> 8%). If uncontrolled diabetes is suspected, 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 mm Hg, or Toe-brachial index \< 0.4). If peripheral vascular disease is suspected, vascular lab testing 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

• Tactile Systems Technology, Inc.: lead

Study Sites (2)

VA Medical Center

Minneapolis, Minnesota, 55417, United States

Location

Wound Healing and Hyperbaric Center

College Station, Texas, 77845, United States

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Sunday Hoy, Director of Clinical Research
• Organization: Tactile Systems Technology, Inc

612.355.5100

Study Officials

• Wade Farrow, MD

  Wound Healing and Hyperbaric Center

  PRINCIPAL INVESTIGATOR

• Sunday Hoy, JD

  Tactile Systems Techonology Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2009
• First Posted: February 19, 2009
• Study Start: September 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: February 12, 2020
• Results First Posted: July 25, 2012

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)