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

Status: Unknown status
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• 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.

Locations
United States
Illinois
Northwestern University
Chicago
Time Frame
Start Date: September 2006
Completion Date: July 2008
Participants
Target number of participants: 30
Treatments
Active Comparator: 1
TheraGauze alone
Active Comparator: 2
Theragauze + Regranex
Sponsors
Leads: Solsys Medical LLC

This content was sourced from clinicaltrials.gov