TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers

Patients will be randomized to receive TheraGauze alone or with Regranex to treat diabetic foot ulcer condition. The purpose of the study is provide the sponsor with pilot information regarding the ability of TheraGauze to promote wound healing on its own and to examine synergy with Regranex in the treatment of diabetic foot ulcers.

Study Overview

• Status: Unknown
• Conditions: Diabetic Foot Ulcer
• Intervention / Treatment: Device: TheraGauze; Drug: Regranex

Detailed Description

This study will evaluate the use of TheraGauzeT (Soluble Systems, LLC) wound dressing, a polymer hydrogel chemically impregnated into a rayon/polyester formed fabric, forming a pliable, conforming solid matrix. TheraGauze is FDA Class I exempt (regulation #21CFR, product code 5878.4022). It is hypothesized that this material will be useful for the treatment of full-thickness diabetic ulcers. It is further hypothesized that this material will enhance the action of Regranex (becaplermin) gel by providing an optimal environment for this growth factor to function. This study will observe patient outcomes following diabetic foot ulcer treatment with TheraGauze and with or without the use of Regranex.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria: Patients

• who are 18 years old or older;
• who are diagnosed as having insulin-dependent or non-insulin-dependent diabetes mellitus (5.5% <HgBA1C<12%);
• who have foot ulcers extending through the epidermis and dermis but not with exposed tendon or bone;
• who have a diagnosis of chronic diabetic ulcer;
• who have a viable wound bed with granulation tissue as determined by bleeding following debridement;
• who have an ulcer size which is at least 1 cm2 and no greater then 16cm2;
• who have signed an informed consent form.
• who have a wound that has been present for at least 4 weeks at the time of screening.

Exclusion Criteria: Patients

• having ulcers less than 1cm2 or greater than 16cm2 in size;
• having severe arterial disease (ankle brachial index (ABI) less than 0.65);
• having history of radiation therapy to the ulcer site;
• who use corticosteroids >10mg prednisone daily
• who use any immune suppressive, or severely immunocompromised patients;
• who have an ulcer that was of a non-diabetic pathophysiology;
• having vasculitis, severe rheumatoid arthritis, or other collagen vascular disease;
• having malnutrition (defined by albumin <2.5 g/dL);
• having a known allergy or hypersensitivity to the components of either TheraGauze or Regranex;
• having erythema or purulence associated with a severe infection of the wound site;
• having signs and symptoms of cellulitis, osteomyelitis, necrotic or avascular ulcer beds;
• undergoing hemodialysis;
• having uncontrolled diabetes (defined as HgB A1c>12%)
• having deficient blood supply to ulcers (defined as capillary fill time >3 seconds at tips of toes)
• having Charcot's neuroarthropathy as determined by clinical and/or radiographic examination;
• having sickle cell disease;
• having exposed bone, tendon, or fascia;
• who are currently enrolled in a clinical evaluation of another investigational device or drug, or have received and investigational treatment for diabetic foot ulcers in the last 30 days;
• unable to comply with the procedures described in the protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 1; TheraGauze alone	Device: TheraGauze; TheraGauze
ACTIVE_COMPARATOR: 2; Theragauze + Regranex	Drug: Regranex; Regranex + TheraGauze

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Frequency of complete wound healing within 12 weeks
Time to complete wound healing within 12 weeks

Secondary Outcome Measures

Outcome Measure
Investigator's or clinician's assessment of wound quality (ulcer duration, baseline area, staging, presence of fibrin or granulation tissue)
Patient's assessment (pain, itching)
Presence of epithelialization visible on the wound surface
Occurrence of infection at the wound site
Recurrence of ulcer during the 20 week follow-up period
Adverse events (infection, cellulites, seroma, etc.)
Excess pain

Collaborators and Investigators

• Sponsor: Solsys Medical LLC
• Investigators: Principal Investigator: Adam Landsman, DPM, PhD, Northwestern University

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (ANTICIPATED): July 1, 2008
• Study Completion (ANTICIPATED): July 1, 2008

Study Registration Dates

• First Submitted: October 18, 2006
• First Submitted That Met QC Criteria: October 18, 2006
• First Posted (ESTIMATE): October 19, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): May 7, 2008
• Last Update Submitted That Met QC Criteria: May 5, 2008
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: Diabetes; Wound; Ulcer; Foot; Extremity; Gauze
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Leg Ulcer; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Diabetic Foot; Foot Ulcer; Ulcer; Physiological Effects of Drugs; Angiogenesis Modulating Agents; Growth Substances; Anticoagulants; Angiogenesis Inducing Agents; Becaplermin
• Other Study ID Numbers: SS-0601