Health Condition 1: null- Diabetic Foot Ulcer
Conditions
Interventions
Intervention1: BioChaperone PDGF-BB: BioChaperone PDGF-BB is applied as a spray every two days at the dose of 4 μg/cm2 for up to 20 weeks + standard wound care + Offloading.
Control Intervention1: No
Sponsors
Virchow Biotech Private Limited
Adocia
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men or women aged 18 years old or older, with type 1 or 2 diabetes mellitus. 2. Patient able and willing to provide informed consent. 3. Patient able to understand and comply with the required visit schedule and all required tests and procedures, including adequate wound care. 4. Patient willing to use an off-loading method during the whole duration of the study. 5. Single full-thickness plantar, lateral or dorsal ulcer of the extremity (below the malleolus), excluding inter-digits ulcer (web spaces), extending through the epidermis and dermis, but not involving bone, tendons, ligaments or muscles (grade IA as defined by University of Texas Diabetic Wound Classification). or Grade 1 according to Wagner classification). 6. Chronic ulcer of at least six weeks despite appropriate wound care. 7. Ulcer area measured with the formula Length x Width x 0.8 following sharp debridement, of 1 to 10 cm², both inclusive. 8. Patient with a single ulcer on the treated feet 9. Well controlled infection or cellulitis (systemic antibiotherapy) before Baseline Visit. 10. Peripheral neuropathy as assessed by Semmes- Weinstein monofilament test or by the bio esthesimeter (vibration perception threshold). 11. Ankle brachial pressure index > 0.60 and 12. Women surgically sterile, post-menopausal, or agree to practice adequate contraception and have a negative pregnancy test at screening and be Non-nursing.
Exclusion criteria
Exclusion criteria: 1. Inter digit ulcers. 2. Ulcer of other cause or origin: electrical, chemical or radiation insult, bedsores, vascular ulcer or Charcot deformities ulcers. 3. Charcot foot. 4. Wound originated from amputation bed. 5. Active ulcer infection assessed by clinical examination and radiography if necessary. Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement or any problem such as cellulitis, gangrene or deep tissue infection that cannot be resolved with standard of care and controlled by standard wound care. 6. Active osteomyelitis affecting the area of the target ulcer. 7. Poorly controlled diabetes (uncontrolled glycemia: HbA1c 10%), renal failure (serum creatinine 3.0 mg/dL), poor nutritional status (albumin 3.0 g/dL or total protein6.5 g/dL).If hypoproteinemia is detected, a 2-weeks daily treatment with 1egg/day may resolve the situation. 8. Known connective tissue or malignant disease. 9. Concomitant treatment with corticosteroids, immunosuppressive agents, radiation therapy, or anticancer chemotherapy. 10. Use of investigational drug/device or growth factor within 30 days. 11. Topical application of any advance wound care on this wound (antiseptics, antibiotics or debriders) within 7 days. 12. Vascular reconstruction within 8 weeks. 13. Patients expected to be noncompliant with the protocol (not available for the duration of the trial, treatment or wound care compliance, study medication application each other day by the family or a nurse), or felt to be unsuitable by the Investigator for any other reason. 14. Patient who cannot tolerate the offlo ding method 15. Morbid obesity as defined by the BMI above or equal to 45Kg/m2 16. A history of severe cerebrovascular events 17. Female patient who has a positive pregnancy test or who is breastfeeding or unwilling to use the appropriate contraceptive methods during study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy outcome measure is the proportion of patients with complete wound healing at the end of the treatment phase of 20 weeks (study endpoint). Timepoint: 20 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy outcome measures: â?¢ time to achieve complete wound closure, â?¢ percentage of reduction in wound area at each visit, â?¢ Gilman Index between each visit and healing rate, â?¢ percentage of patients with complete wound healing at week 10 and â?¢ recurrence of ulcer on the initial site or at any other site Timepoint: 20 Weeks. | — |
Countries
India
Contacts
Public ContactMr Srinivasa Rao Capilayee
MakroCare Clinical Research Ltd.
Outcome results
None listed