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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00389636
Recruitment Status : Unknown
Verified May 2008 by Solsys Medical LLC.
Recruitment status was:  Active, not recruiting
First Posted : October 19, 2006
Last Update Posted : May 7, 2008
Information provided by:
Solsys Medical LLC

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetic Foot Ulcer Device: TheraGauze Drug: Regranex Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : September 2006
Estimated Primary Completion Date : July 2008
Estimated Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Becaplermin

Arm Intervention/treatment
Active Comparator: 1
TheraGauze alone
Device: TheraGauze

Active Comparator: 2
Theragauze + Regranex
Drug: Regranex
Regranex + TheraGauze

Primary Outcome Measures :
  1. Frequency of complete wound healing within 12 weeks
  2. Time to complete wound healing within 12 weeks

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00389636

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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Solsys Medical LLC
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Principal Investigator: Anne Laumann, MBChB, MRCP Northwestern University
Principal Investigator: Adam Landsman, DPM, PhD Northwestern University
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Responsible Party: Allan Staley, Soluble Systems, LLC Identifier: NCT00389636    
Other Study ID Numbers: SS-0601
First Posted: October 19, 2006    Key Record Dates
Last Update Posted: May 7, 2008
Last Verified: May 2008
Keywords provided by Solsys Medical LLC:
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Angiogenesis Inducing Agents
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs