This prospective Randomized study comparing sSilvrSTAT Gel dressing with conventional dressing in patients with non ischemic diabetic foot ulcers Foot ulcer,
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria 1-Type I or II DM on either oral hypoglycemic or insulin therapy. 2-Presence of revascularized non-ischemic DFUs after successful bypass surgery or endovascular intervention. 3- Presence of a foot ulcer for at least 6 weeks duration. 4-No clinical evidence of infection at the ulcers site. 5-Wagner type I or II ulcers.
Exclusion criteria
Exclusion criteria: Exclusion criteria 1-Wagner type III, IV and V ulcers. 2-Peripheral artery disease (PAD). 3-Clinical signs of infection. 4-Presence of gangrene in the ulcer or any part of foot 5-Patients with a history of suspected osteomyelitis 6-Surface area of ulcer Ë‚ 2cm2. 7-Exposure of bone, tendon, and ligament at ulcer bed. 8-Patients with a history of radiation or chemotherapy within three months of randomization. 9-Low serum albumin (Ë‚ 3 g/dl). 10-History of silver hypersensitivity. 11-Patients on renal dialysis, immunocompromised, history of liver, hematological, nutritional, collagen, and vascular diseases. 12-Patients with active cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total surface area of the ulcer 2.5 yeras measuring surface area of ulcer by calculation of length, depth and width of the ulcer usng ruler an | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of infection and major limb amputations. 2.5 yeras clinical observation | — |
Countries
Egypt
Contacts
Prince Mohammed Bin Abd El-Aziz Hospital, Riyadh, Saudi Arabia