Efficacy of a natural polymer solution product for the prevention of wet gangrene
- Conditions
- Diabetic complications, gangrene, atheroschlerosis, peripheral arterial diseaseNutritional, Metabolic, EndocrineOther bacterial diseases, not elsewhere classified
- Registration Number
- ISRCTN72459118
- Lead Sponsor
- The Scientific Chair of Sheikh Mohammad Hussein Al-Alamoudi for Diabetic Foot Research (Saudi Arabia)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
1. Patients with diabetes
2. Patients who presented with peripheral dry well-demarcated gangrene in their feet who were offered the option to wait for non-surgical autoamputation
3. Geriatric, bed-ridden patients with diabetes who refused amputation and/or were contra-indicated for re-vascularization or surgery
4. Any patient above 40 years of any gender
Patients were allowed to withdraw at any time.
1. Patients with evidence of wet/infected gangrene that was confirmed by microbiological culture
2. Patients currently on antibiotics. These patients could enter the study 1 week after complete cessation of initial antibiotic therapy.
3. Patients with uncontrollable local and/or systemic infection requiring antibiotics, surgical amputation and/or local debridement
4. Patients in whom infection showed signs of spreading
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Patient death<br>2. Rates of surgical amputation and /or debridement of gangrenous tissues<br>3. Rates of auto-amputation of gangrenous tissues<br>4. Performance of vascular revascularization procedure
- Secondary Outcome Measures
Name Time Method 1. Rates of local and/or systemic infection<br>2. Extension of gangrene to adjacent healthy tissues <br>3. Progression of dry to wet gangrene