Health Condition 1: null- chronic diabetic foot ulcer
Conditions
Interventions
Intervention1: ReliDerm®
DT: Weekly topical application. maximum upto 8 weeks
Control Intervention1: Standard Care of treatment: Weekly upto complete healing
Sponsors
Reliance Life Sciences PvtLtd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or female between 18-80 years of age 2. Patient with current diagnosis of Type Î? or Î?Î? Diabetes mellitus with controlled blood sugar level at the time of application. 3.Wound that extends through the dermis and into subcutaneous tissue (granulation tissue may be present) but without exposure of muscle, tendon, bone or joint capsule at the time of application 4.Patientâ??s ulcer on foot, sole or heel (below ankle) 5.Patient with not more than one ulcer on the study foot 6.Ulcer of >=6 weeks duration (ulcers not responding to routine line of treatment i.e non healing ulcer) 7. Postdebridement ulcer with an area of approximately 6-10 cm2 and depth of >=2 mm. 8. Patientâ??s wound (after Debridement) free of necrotic debris and exhibits no sign of clinical infection 9.Patient with adequate peripheral arterial circulation as determined by palpable dorsalis pedis or posterior/anterior tibial artery and by Doppler on the study foot. 10.The subject is willing and is able to read, understand and sign the study specific informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patient ulcer shows evidence of cellulitis, active osteomyelitis or other clinical infection. 2. Patient?s ulcer has increased or decreased in size by 50% or more during the screening period. 3. Patient with a known history of any major metabolic disorder like myxedema 4. Patient receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents, coumadin, heparin or is anticipated to receive such agents 5. Patient has a history of bleeding disorder or clotting disorder 6. Severe protein malnutrition as evidenced by serum albumin <2.0g/dl 7. Severe anaemia Hb<7 g/dl 8. Infection with Human Immunodeficiency Virus (HIV) or Hepatitis B (HbsAg)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Wound ClosureTimepoint: Complete Wound Closure at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To study time to complete wound healing 2. To study partial healing of wound as compared to baseline 3. To study Immunogenicity 4. To determine safetyTimepoint: 12 weeks | — |
Countries
India
Contacts
Public ContactDr Chandra Viswanathan
Reliance Life Sciences Pvt. Ltd.
Outcome results
None listed