CTRI/2011/09/001985
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 Venous Leg Ulcers - Nil
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: null- Venous Leg 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\. Subjects with ulcers of venous origin, as clinically determined by the investigator by a positive venous reflux test (venous refilling \<20 seconds) using Doppler ultrasound for at least 4 weeks prior to screening day, which have not adequately responded to conventional ulcer therapy.
- •4\. Ulcers that extend through the epidermis but not through muscle, tendon, or bone (Stage II or III ulcers as defined by the IAET).
- •5\. Surface ulcer between 0\.5 cm2 and 40 cm2 post debridement.
- •6\. 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 or comply with compression therapy.
- •3\. An ulcer which shows signs of severe clinical infection, defined as pus oozing from ulcer site.
- •4\. The ulcer to be treated requires operative debridement.
- •5\. An ulcer positive for \_\-hemolytic streptococcus upon culture.
- •6\. The ulcer has more than 50% slough, significant necrotic tissue, osteomyelitis, bone, tendon, or capsule exposure or avascular ulcer beds.
- •7\. Highly exuding wounds (wounds that require a daily dressing change).
- •8\. ABPI 0\.65\.
- •9\. Subjects with active systemic infections.10\. Subjects with clinically significant medical conditions as determined by the Investigator which would impair wound healing including renal, hepatic, hematologic, neurologic or immune disease. Examples include but are not limited to:
- •a. Renal insufficiency as an estimated GFR which is 30 mL/min/1\.7m2\.b. Abnormal blood biochemistry defined as 3 times that of the upper limit of the normal range.c. Hepatic insufficiency defined as total bilirubin 2 mg/dL or serum albumin 25 g/L.d. HbA1c 9\.0%.e. Hemoglobin 10 g/dL.f. Hematocrit 0\.30\. g. Platelet count 100,000\.
Outcomes
Primary Outcomes
Not specified
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