CTRI/2011/09/001984
Completed
Phase 2
A Phase II, Randomized, Prospective, Double blind, Parallel group, Multi-center Study to determine the Safety and Efficacy of GRANEXIN GEL in the Treatment of Diabetic Foot Ulcers - Nil
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Diabetic Foot Ulcer
- Sponsor
- FirstString Research Inc
- Enrollment
- 92
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female aged 18 years and older.
- •2a. Female subjects must be post\-menopausal or surgically sterilized.
- •2b. Female of child\-bearing potential must have negative pregnancy test at screening, and agrees to use hormonal contraceptive or intra\-uterine device (IUD) or diaphragm with spermicide or condom with spermicide or abstinence throughout the study.
- •3\. Diabetes mellitus (type I or II) with an HbA1c \< 10\.0%.
- •4\. Diagnosis of neuropathic foot ulcer.
- •5\. Cutaneous, full thickness (University of Texas grade A1\), below ankle surface ulcer between 0\.5 cm2 and 40 cm2 post debridement.
- •6\. A viable, granulating wound as per investigators discretion.
- •7\. Ulcer present for at least 4 weeks prior to screening day.
- •8\. An Ankle Brachial Index between 0\.70 and 1\.3 measured at screening.
- •9\. Signed informed consent form.
Exclusion Criteria
- •1\. Decrease or increase in the ulcer size by 30% or more during 7 day screening period.
- •2\. Cannot tolerate the off\-loading method or comply with standard of care.
- •3\. An ulcer which shows signs of severe clinical infection, defined as pus oozing from the ulcer site.
- •4\. The ulcer to be treated requires operative debridement.
- •5\. An ulcer positive for \_\-hemolytic streptococcus upon culture.
- •6\. Requirement for total contact casts.
- •7\. The ulcer has more than 50% slough, significant necrotic tissue, bone, tendon, or capsule exposure.
- •8\. Highly exuding wounds (wounds that require a daily dressing change).
- •9\. ABPI 0\.7 or 1\.3 or ankle systolic pressure 70 mm Hg.
- •10\. Subjects with systemic infections.1
Outcomes
Primary Outcomes
Not specified
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