This trial is active, not recruiting.

Condition diabetic foot ulcer
Treatments theragauze, regranex
Sponsor Soluble Systems, LLC
Start date September 2006
End date July 2008
Trial size 30 participants
Trial identifier NCT00389636, SS-0601


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
TheraGauze alone
(Active Comparator)
Theragauze + Regranex
Regranex + TheraGauze

Primary Outcomes

Frequency of complete wound healing within 12 weeks
time frame:
Time to complete wound healing within 12 weeks
time frame:

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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% 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.

Additional Information

Official title TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers
Principal investigator Anne Laumann, MBChB, MRCP
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2008.
Information provided to ClinicalTrials.gov by Soluble Systems, LLC.