Effect of supplementation in treatment of patients with diabetic foot

Phase 2

• Conditions: Non-insulin-dependent diabetes mellitus and with peripheral circulatory complications; E11 and E1; Diabetic foot.

• Registration Number: IRCT201604025623N72
• Lead Sponsor: Kashan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 5 November 2019

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients with diabetic foot;
Aged 40 to 85 years

Exclusion Criteria

Grade 3 DFU with abscess formation and osteomyelitis
Subjects with significant arterial disease
Major deformities e.g. Charcot's neuroarthropathy
Pregnant and breastfed patients
Taking antioxidant and/or anti-inflammatory supplements such as vitamin E, vitamin C and omega-3 fatty acids
Change in consuming medications throughout the study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula.;Healing of diabetic foot ulcer. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Decrease of the wound size relative to original size: ulcer length (cm), ulcer width (cm), Ulcer depth (cm).