Diabetic complications, gangrene, atheroschlerosis, peripheral arterial disease Nutritional, Metabolic, Endocrine Other bacterial diseases, not elsewhere classified
Conditions
Interventions
Patients were allocated to receive either topical application of PVP-I (conventional treatment) or 'Shellac' solution to the necrotic areas.
Shellac was applied by soaking a 4 × 4 cm sterile gauze in
Sponsors
The Scientific Chair of Sheikh Mohammad Hussein Al-Alamoudi for Diabetic Foot Research (Saudi Arabia)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Patient death 2. Rates of surgical amputation and /or debridement of gangrenous tissues 3. Rates of auto-amputation of gangrenous tissues 4. Performance of vascular revascularization procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Rates of local and/or systemic infection 2. Extension of gangrene to adjacent healthy tissues 3. Progression of dry to wet gangrene | — |
Countries
Saudi Arabia
Outcome results
None listed