Comparative study between silver nanoparticles dressing (SilvrSTAT Gel) and conventional dressing in diabetic foot ulcer healing: a prospective randomized study
- Conditions
- This prospective Randomized study comparing sSilvrSTAT Gel dressing with conventional dressing in patients with non ischemic diabetic foot ulcersFoot ulcer,SilvrSTAT,Gel,conventional,dressing,moist.
- Registration Number
- TCTR20200630002
- Lead Sponsor
- Faculty of medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Rate of infection and major limb amputations. 2.5 yeras clinical observation