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
Recruitment status was Active, not recruiting
Sponsor:
Soluble Systems, LLC
Information provided by:
Soluble Systems, LLC
ClinicalTrials.gov Identifier:
NCT00389636
First received: October 18, 2006
Last updated: May 5, 2008
Last verified: May 2008
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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
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 May 22, 2013