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Comparative study between silver nanoparticles dressing (SilvrSTAT Gel) and conventional dressing in diabetic foot ulcer healing: a prospective randomized study

Comparative study between silver nanoparticles dressing (SilvrSTAT Gel) and conventional dressing in diabetic foot ulcer healing: a prospective randomized study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200630002
Enrollment
Unknown
Registered
2020-06-30
Start date
2017-03-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

This prospective Randomized study comparing sSilvrSTAT Gel dressing with conventional dressing in patients with non ischemic diabetic foot ulcers Foot ulcer&#44

Interventions

Group A: SilvrSTAT Gel was applied directly to the ulcer after cleaning with a surgical soap solution then covered with a conventional dressing. The frequency of dressing change was of every 72 hours.
Active Comparator Other,Active Comparator Other
SilvrSTAT Gel dressing,Conventional dressing

Sponsors

Faculty of medicine
Lead Sponsor
Benha university
Collaborator

Eligibility

Sex/Gender
All
Age
50 Years to 62 Years

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

MeasureTime 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

MeasureTime frame
Rate of infection and major limb amputations. 2.5 yeras clinical observation

Countries

Egypt

Contacts

Public Contactkhaled ahmad

Prince Mohammed Bin Abd El-Aziz Hospital, Riyadh, Saudi Arabia

khaled.ahmad.md@gmail.co0597881317

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026