Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications
Conditions
Interventions
None listed
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients with age between 18 to 70 years 2. Clinically diagnosed diabetes (HbA1c greater than 6.5 %) and with diabetic foot ulcers as per University of Texas Grade 1 or 2 with stage A or B and size between 15 to 40 cm2 3. Uninfected Diabetic foot ulcers or Diabetic foot ulcers with mild infection as per International Working Group on the Diabetic Foot (IWGDF) and Infectious Disease Society of America (IDSA) (Matilde Monteiro-Soares et al. 2019) 4. Diabetic foot ulcers less than 2 weeks old at the time of screening 5. Willing to give consent for participating in the study
Exclusion criteria
Exclusion criteria: 1. Patients with necrosis, purulence, or sinus tracts in the target ulcer not removable by debridement 2. Compromised blood flow as indicated by USG colour Doppler report for the affected limbs anterior tibial, posterior tibial, and dorsalis pedis arteries which the treating physician feels may affect the ulcer healing 3. Patients undergone prior amputation due to diabetic wounds 4. HbA1c greater than 12% 5. Patients on regular medicines which may affect wound healing (corticosteroids, immunosuppressive drugs, cancer chemotherapy, NSAIDs, anticoagulants and anticonvulsant drugs) 6. Pregnant and lactating women 7. Any condition which in the opinion of the investigator will place the subject at risk or will influence the conduct of the study or interpretation of results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Proportion of participants achieving complete healingTimepoint: 4 week 6 week 8 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in ulcer size (surface area)Timepoint: Baseline 1 week 2 week 4 week 6 week 8 week;Quality of life using WHO QoL-BREF questionnaireTimepoint: Baseline 8 week;Safety: Adverse events for Safety outcomes at any follow-up, infection rate of ulcerTimepoint: 1 week 2 week 4 week 6 week 8 week | — |
Countries
India
Contacts
Public ContactDr Harsha Hegde
ICMR National Institute of Traditional Medicine Belagavi
Outcome results
None listed