Studying the Effect of prolotherapy in diabetic foot ulcer
Not Applicable
Recruiting
- Conditions
- Diabetic foot ulcer.Diabetes mellitus due to underlying condition
- Registration Number
- IRCT20220424054636N1
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Age > 18 years old
Patients with confirmed type 1 or 2 diabetes mellitus
HbA1C = 7-10%
Ability to understand and collaborate during the study
Having at least one chronic ulcer lasting for more than 4 weeks
Plantar or dorsal or malleolar ulceration
ABI = 0.7 - 1.2 in ischemic ulcers
Ulcers with Wagner grades 2, 3
Ulcers with wound area = 1-20 cm2
None of the patients had received glucocorticoid, estrogen, or other drugs that interfere healing process within the past 1 month
Patients who signed the informed consent
Exclusion Criteria
Patients with a history of malignancy or coagulopathy
GFR < 30 ml/min/1.73m2
Albumin level < 3.5 g/dl
Pregnancy
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Wound area. Timepoint: Before intervention and 7, 14, 21 and 28 days after intervention. Method of measurement: Digital imaging to measure wound area.;Patient's pain scale. Timepoint: Before intervention and 7, 14, 21 and 28 days after intervention. Method of measurement: Visual Analogue Scale.
- Secondary Outcome Measures
Name Time Method White blood cell. Timepoint: Before and after intervention. Method of measurement: Complete blood cells test.;Erythrocyte sedimentation rate. Timepoint: Before and after intervention. Method of measurement: Quantitative measurement of erythrocyte sedimentation rate in blood.;C-reactive protein. Timepoint: Before and after intervention. Method of measurement: Quantitative measurement of C-reactive protein in blood.;Blood glucose. Timepoint: Before and after intervention. Method of measurement: Glucometry.;Ankle - Brachial index. Timepoint: Before and after intervention. Method of measurement: Doppler sonography.