Chronic diabetic foot Ulcer. Type 2 diabetes mellitus with foot ulcer
Conditions
Interventions
Intervention 1: Intervention group: in this group, the patients will use TEBADERM dressing on their granulated wound daily. the dressing will be changed every 24 hours. Intervention 2: Control group:
Treatment - Devices
Intervention group: in this group, the patients will use TEBADERM dressing on their granulated wound daily. the dressing will be changed every 24 hours.
Control group: in this group, the patients will use standard dressing which it moisturizes with normal saline every 6 hours.
Sponsors
Iranian academic center for education culture and research
Tebazist Polymer
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Chronic neuropathic diabetic foot ulcer (more than 6 weeks) with wound classification Wagner I & II full informed consent for recruitment in random allocation
Exclusion criteria
Exclusion criteria: Suspected osteomyelitis Evidence of severe Ischemia (ABI less than 0.8) ESR more than 70 Using corticosteroid or immuno-suppressor drug Chronic renal failure of Hemodialysis Charco Joint Suspected malignancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete wound healing during study (at least 6 months). Timepoint: every month up to Month 6th. Method of measurement: inspection.;Changes of wound area. Timepoint: week 1, 2, 3, 4, 6 month 3, 4, 6. Method of measurement: photography. | — |
Secondary
| Measure | Time frame |
|---|---|
| IV Antibiotic therapy. Timepoint: every month up to month 6th. Method of measurement: clinical examination. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactGholamreza Esmaeeli Djavid
Iranian academic center for education culture and research
Outcome results
None listed