Diabetic Foot. Diabetes mellitus
Conditions
Interventions
Intervention 1: Treatment of diabetic foot ulcers with Royal Jelly, follow up twice a week for 6 months with precise measurements (With digital measurement device), evaluation of diameter, depth, perc
Treatment - Drugs
Treatment of diabetic foot ulcers with Royal Jelly, follow up twice a week for 6 months with precise measurements (With digital measurement device), evaluation of diameter, depth, percentage of healin
Treatment of diabetic foot ulcers with placebo gel, follow up twice a week for 6 months with precise measurements (With digital measurement device), evaluation of diameter, depth, percentage of healin
Sponsors
Isfahan University Of Medical Sciences and Health Services
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Mansour Siavash
Isfahan Medical University
Outcome results
None listed