Determination of the efficacy of royal jelly dressing on the healing of diabetic foot ulcer

Phase 2

Conditions: Diabetic Foot.
Diabetes mellitus
E10, E11,

Registration Number: IRCT201009263278N2

Lead Sponsor: Isfahan University Of Medical Sciences and Health Services

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 70

Inclusion Criteria

Exclusion criteria:
1) Drug side effects (hypersensitivity to RJ)
2) Inappropriate follow up by the patient (i.e., if the patient does not refer for 3 continuous sessions or if the patient attends less than 50% of the total sessions.)
3) Patient’s desire for leaving in each stage of the study
4) Presence of no change in the ulcer (i.e., infection, diameter, and depth reduction) by the end of 12th week of the study (These patients will be mentioned as non responder cases in the final analysis.)
Conditions of not including:
1) Patient preference for receiving the treatment out of the study
2) Foot gangrene such that a surgical treatment is required
3) Severe sepsis (at the presentation until recovery)
4) Impending gangrene until angioplasty will be done
5) Use of drugs which may interact with wound healing (e.g., Glucocorticoids,etc)

Exclusion Criteria

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diameter reduction rate. Timepoint: twice a week for 6 months. Method of measurement: evaluation of diameter with precise measurement with Digital measurement device.;Depth reduction rate. Timepoint: twice a week for 6 months. Method of measurement: evaluation of depth of wound with precise measurement with sterile probe with Digital measurement device.;Percentage of complete healing. Timepoint: twice a week for 6 months. Method of measurement: evaluation of percentage of complete healing with precise measurement with Digital measurement device.

Secondary Outcome Measures