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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Soluble Systems, LLC.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Soluble Systems, LLC
ClinicalTrials.gov Identifier:
NCT00389636
First received: October 18, 2006
Last updated: May 5, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention
Diabetic Foot Ulcer
Device: TheraGauze
Drug: Regranex

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers

Resource links provided by NLM:


Further study details as provided by Soluble Systems, LLC:

Primary Outcome Measures:
  • Frequency of complete wound healing within 12 weeks
  • Time to complete wound healing within 12 weeks

Secondary Outcome Measures:
  • 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

Enrollment: 30
Study Start Date: September 2006
Estimated Study Completion Date: July 2008
Estimated Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
TheraGauze alone
Device: TheraGauze
TheraGauze
Active Comparator: 2
Theragauze + Regranex
Drug: Regranex
Regranex + TheraGauze

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00389636

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Soluble Systems, LLC
Investigators
Principal Investigator: Anne Laumann, MBChB, MRCP Northwestern University
Principal Investigator: Adam Landsman, DPM, PhD Northwestern University
  More Information

No publications provided

Responsible Party: Allan Staley, Soluble Systems, LLC
ClinicalTrials.gov Identifier: NCT00389636     History of Changes
Other Study ID Numbers: SS-0601
Study First Received: October 18, 2006
Last Updated: May 5, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Soluble Systems, LLC:
Diabetes
Foot
Extremity
Ulcer
Wound
Gauze

Additional relevant MeSH terms:
Ulcer
Foot Ulcer
Diabetic Foot
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Platelet-derived growth factor BB
Angiogenesis Inducing Agents
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014