Health Condition 1: L99- Other disorders of skin and subcutaneous tissue in diseases classified elsewhere
Conditions
Interventions
Intervention1: Growth Factor Concentrate: Autologus Growth Factor Concentrate generated from subjects/participants blood sample
Study duration will be of 70 Days
Control Intervention1: Standard of car
Sponsors
Dr Ketan Vagholkar
Eligibility
Inclusion criteria
Inclusion criteria: 1 An adult (at least 18 years of age) of any gender with type 1 or 2 diabetes mellitus with controlled blood glucose level 2. Patient with a single chronic ulcer of at least one month despite appropriate wound care 3. Grade I or II of Maggitt Wagner classification system 4. Ulcer size with surface area of =1cm2 =25cm2 after debridement with well controlled infection not requiring skin graft 5. Adequate arterial blood supply measured by (color) doppler ultrasonography or palpable pulse of dorsalis pedis / posterior tibial artery 6. Women surgically sterile, post-menopausal, or agree to practice adequate contraception and have a negative pregnancy test at screening. Non-nursing women. 7. Patient able and willing to provide informed consent 8. Patient able and willing to comply with protocol visits and procedures
Exclusion criteria
Exclusion criteria: 1. Inter digit ulcers or Wound originated from amputation bed 2. Ulcer of other cause or origin: electrical, chemical or radiation insult, bedsores, vascular ulcer or Charcot deformities ulcers 3. Active ulcer infection assessed by clinical examination and radiography if necessary or Active osteomyelitis affecting the area of the target ulcer (Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement and controlled by standard wound care.) 4. Poorly controlled diabetes (uncontrolled glycaemia: HbA1c% = 10%), renal failure (serum creatinine > 2.0 mg/dL), poor nutritional status (albumin 200 mg/dL 5. Patients who are Hepatitis B or C or HIV or VDRL/RPR positive. 6. Known connective tissue or malignant disease or history of severe cerebrovascular events. 7. Concomitant treatment with corticosteroids, immunosuppressive agents, radiation therapy, or anticancer chemotherapy 8. Use of investigational drug/device or growth factor within 30 days of screening 9. Previous treatment of advanced therapy (other than standard of care) for lower extremity diabetic ulcer including Negative Pressure Wound Therapy (NPWT) device or hyperbaric oxygen or growth factor within 7 days of screening 10. Patients with blood dyscrasias, patients on anticoagulants/ antiplatelet or with actively bleeding wounds or hemoglobinopathy 11. Pregnancy, Breast feeding, Nursing mother or fertile woman not practicing birth control 12. Patients expected to be noncompliant with the protocol or felt to be unsuitable by the Investigator for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with appearance of healthy granulation tissue covering = 75% ulcer size - surface area (baseline) at TOC/Visit 17 (Healthy granulation tissues should have serous exudate, very fine granules, bright red in colour and bleed on touch)Timepoint: 70 Days, visit every 5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with complete wound closure at TOC/Visit 17 (Complete wound closure is defined as 100% epithelisation, normal coloration with no marginal recurrence, complete absence of exudate and no clinical signs of infection) Mean percent reduction of ulcer size (surface area) at TOC/Visit 17 Time to appearance of healthy granulation tissue covering = 75% of ulcer surfaceTimepoint: 70 Days | — |
Countries
India
Contacts
Public ContactDr Kaushal Kapadia
Wockhardt Ltd
Outcome results
None listed