Condition 1: Treatment of chronic neuropathic diabetic foot ulcers. Condition 2: Treatment of chronic neuropathic diabetic foot ulcers. Condition 3: Treatment of chronic neuropathic diabetic foot ulcers. Type 2 diabetes mellitus with foot ulcer Type 1 diabetes mellitus with foot ulcer Type 2 diabetes mellitus with diabetic neuropathy, unspecified
Conditions
Interventions
Intervention 1: 40 volunteer patients who refer to the Wound and Tissue Repair Research Center of the University of Medical Sciences, Academic Center for Education, Culture, and Research, will be exam
Sponsors
Iranian academic center for education culture and research
Eligibility
Sex/Gender
All
Age
30 Years to 70 Years
Inclusion criteria
Inclusion criteria: Chronic diabetic ulcers (more than 6 weeks) grade I-II Wagner classification without osteomyelitis Full thickness ulcer The size of the wound has to be between1-8 cm2 Controlled blood sugar (HbA1c less than 10) Patient's consent and clarification on whether they may be concluded in control or treatment group Non responsive ulcers to previous medications and treatments
Exclusion criteria
Exclusion criteria: Ulcers that are classified as grade 3-4 of Wagner classification or osteomyelitis has occurred Patients that don't meet the age criteria of the study High blood sugar levels The wounds that do not include full layers of skin. The wounds healed by other standard diabetic ulcers treatment methods
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Full thickness closure progress. Timepoint: Before treatment, the first, second, fourth, fifth, and sixth weeks and again on third, fourth, fifth, and sixth-months post-treatment. Method of measurement: On each evaluation period, the wounds will be measured with special devices like a ruler specialized for wound measurements. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of local side effects (irritation, inflammation, pain, granulation, infection). Timepoint: Before treatment, the first 48 hours, and again from the first week till week six of the study. Method of measurement: Clinical observation.;Evaluation of systematic side effects (skin sensitivity, fever, shivering, nausea, vomiting). Timepoint: Before treatment, the first 48 hours, and again from the first week till week six of the study. Method of measurement: Clinical observation.;The rate of wound healing. Timepoint: Before treatment, then from first week till week six and then every month till six months post treatment. Method of measurement: Clinical observation.;Duration of complete wound healing. Timepoint: From week one, till week six, and then every month till six months post-treatment. Method of measurement: Clinical observation.;Side effects of choronic diabetic wounds on patients ( the need of antibiotics prescription and Hospitalization). Timepoint: From week one, till week six, and then every month till six months post-treatment. Method of measurement: Clinical observation. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactGholamreza Esmaeil Javid
Iranian academic center for education culture and research
Outcome results
None listed