Health Condition 1: null- Diabetic Foot Ulcers Health Condition 2: E116- Type 2 diabetes mellitus with other specified complications
Conditions
Interventions
Intervention1: 1.BioChaperone PDGF-BB Low Dose 2. BioChaperone PDGF-BB High Dose,
3. BioChaperone PDGF-BB very Low Dose: 1. BioChaperone PDGF-BB Low Dose, in which BioChaperone PDGF-BB is applied as a
2. BioChaperone PDGF-BB High Dose, in which BioChaperone PDGF-BB is applied as a spray every two days at the dose of 25 µg/cm2 for up to 20 weeks
Very Low Dose in which BioChaperone PDGF-BB is applied as a spray every two days at the dose of 4 µg/cm2 for up to 20 weeks
Control Intervention1: Becaplermin gel: 3. Becaplermin gel 100 µ
g/g (Regranex®
Gel 0.01%), in which becaplermin gel is applied once daily at the dose of 6.25 µ
g/cm2 for up to 20 weeks.
Sponsors
Adocia
Eligibility
Inclusion criteria
Inclusion criteria: 1.Men or women aged 18 years old or older, with type 1 or 2 diabetes mellitus. 2.Single full-thickness plantar ulcer of the extremity (below the malleolus) 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). 3.Chronic ulcer of at least six weeks but no more than three months despite appropriate wound care. 4.Ulcer area (greatest length by greatest width), following sharp debridement, of 1 to 10 cm², both inclusive. 5.Well controlled infection or cellulitis (systemic antibiotherapy). 6.Peripheral neuropathy as assessed by Semmes-Weinstein monofilament test or by the bio esthesimeter (vibration perception threshold). 7.Adequate arterial blood supply, to be measured by (color) doppler ultrasonography, ankle brachial pressure index 0.60, or ankle systolic pressure 70 mmHg or toe pressure 30 mmHg. Ankle brachial pressure index should be lower than 1.3 (which is frequently related to medial artery calcification. 8.Women surgically sterile, post-menopausal, or agree to practice adequate contraception and have a negative pregnancy test at screening. Non-nursing. 9.Signed informed consent before any study procedure.
Exclusion criteria
Exclusion criteria: 1.Ulcer of other cause or origin: electrical, chemical or radiation insult, bedsores, vascular ulcer or Charcot deformities ulcers. 2.Active ulcer infection assessed by clinical examination and radiographic if necessary. Presence of necrosis, purulence or sinus tracts that cannot be removed by debridement. 3.Active osteomyelitis affecting the area of the target ulcer. 4.Poorly controlled diabetes (uncontrolled glycemia: HbA1c &#8805; 12%), renal failure (serum creatinine > 3.0 mg/dL), poor nutritional status (albumin < 3.0 g/dL or total protein < 6.5 g/dL). 5.Known connective tissue or malignant disease. 6.Concomitant treatment with corticosteroids, immunosuppressive agents, radiation therapy, or anticancer chemotherapy. 7.Use of investigational drug/device within 30 days. 8.Topical application of any advance wound care on this wound (Growth Factor, antiseptics, antibiotics or debriders) within 7 days. 9.Vascular reconstruction within 8 weeks. 10.Patients expected to be noncompliant with the protocol (not available for the duration of the trial, treatment or wound care compliance), or felt to be unsuitable by the Investigator for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of complete wound closure.Timepoint: 20 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to achieve complete wound closure,Timepoint: ;2.Percentage of reduction in wound areaTimepoint: 20 weeks;3. Percentage of patients with complete wound healing at week 10Timepoint: 10 weeks | — |
Countries
India
Contacts
Public ContactDr Hemanth Nandigala
Executive Director (Comm)
Outcome results
None listed