MedPath

Dermaheal Effect on Diabetic Foot Ulcer

Phase 3
Conditions
Diabetic Foot Ulcer.
Type 2 diabetes mellitus with neurological complications
E11.4
Registration Number
IRCT20080904001199N4
Lead Sponsor
Darudarman Salafchegan Co. (Knowledge-based)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
50
Inclusion Criteria

Wagner G 1&2 Diabetic Foot Ulcer
Neuropathic and Neuroischemin Ulcer 0.7 = ABI = 1.2

Exclusion Criteria

Patient Disagreement to Participate
Use of Medications that can Interfere with Wound Healing such as Corticosteroids, Immunosuppressive agents, and Cytotoxic agents

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
lcer Area. Timepoint: End of every week. Method of measurement: Images & and ruler.;Wound Discharge. Timepoint: End of every week. Method of measurement: Color, odor and amount by wound healing checklist.;Surrounding tissues. Timepoint: End of every week. Method of measurement: Color, hotness, edema and sense by wound healing checklist.
Secondary Outcome Measures
NameTimeMethod
ABI. Timepoint: End of treatment. Method of measurement: ABI measurement Device.;FBS. Timepoint: End of treatment. Method of measurement: Glucometer.;Pain severity. Timepoint: End of every week. Method of measurement: Visual pain scale.
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