Health Condition 1: L896- Pressure ulcer of heel
Conditions
Interventions
Intervention1: Low level laser therapy: low level laser therapy will be given to experimental group for 4 days per week for 6 weeks total
Control Intervention1: Offloading Footwear: pressure relief fo
Sponsors
NIL
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female between 40-65 years of age 2. Participants diagnosed with open plantar foot wound and history of type 2 diabetes mellitus. 3. Participants diagnosed with Grade 1 or Grade 2 DFU on the Wagner classification tool. 4. Participants who have an DFU with a total surface area less than 15cm2. 5. Participants and/or caregiver willing and able to comply with all study procedures and scheduled follow-up visits, for the duration of the study.
Exclusion criteria
Exclusion criteria: 1. Participants without capacity to consent or those who do not provide informed consent. 2. Unwilling to continue with their standard wound care therapy for the study duration. 3. Patients with BMI more than 30. 4. Clinical evidence of infection or gangrene in any part of the affected foot or leg. 5. History of bone cancer, metastatic disease, radiation or chemotherapy to the affected limb within the 12 months prior to screening visit. 6. Suspected or confirmed malignancy of the wound. 7. Participation in another drug or device study for the treatment of DFU within 30 days of screening visit. 8. Vascular procedures performed within 30 days of screening visit. 9. Active bleeding tissue or untreated hemorrhagic conditions. 10. Active or suspected DVT or thrombophlebitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pressure ulcer scale for healing (PUSH)Timepoint: at baseline, 2 weeks, 4 weeks, 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Reported time of healingTimepoint: at baseline and at full recovery of wound;Diabetic foot ulcer scaleTimepoint: at baseline, 2 weeks, 4 weeks, 6 weeks | — |
Countries
India
Contacts
Public ContactMr Roshan Lal Meena
Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities
Outcome results
None listed