Phase II Study to Evaluate the Efficacy and Safety of Topical BB-101 for the Treatment of Diabetic Lower Leg and Foot Ulcers
Overview
- Phase
- Phase 2
- Intervention
- BB-101
- Conditions
- Diabetic Foot Ulcer
- Sponsor
- Blue Blood Biotech Corp.
- Enrollment
- 96
- Locations
- 5
- Primary Endpoint
- Efficacy Evaluation
- Status
- Recruiting
- Last Updated
- 10 days ago
Overview
Brief Summary
This is a randomized, double-blinded, vehicle-controlled, parallel, phase II study to evaluate the efficacy and safety of topical BB-101 for the treatment of diabetic lower leg and foot ulcer.
Detailed Description
This is a randomized, double-blinded, vehicle-controlled, parallel, phase II study to evaluate the efficacy and safety of topical BB-101 for the treatment of diabetic lower leg and foot ulcer. All subjects will receive standard-of-care ulcer treatment from screening through the last study visit. The study will be conducted at multiple investigational sites located in Taiwan. Additional sites and countries may be added during the course of the study if required.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female, at least 20 years of age (inclusive) at the date of Screening
- •Subject or legally authorized representative who is able to understand the nature of this study and accepts to enter the study by signing written informed consent
- •Subject agrees to comply with ulcer care regimen for the duration of the study and is willing to return for all mandatory visits as defined in the protocol
- •Subject with Type 1 or Type 2 diabetes mellitus (criteria for the diagnosis of diabetes mellitus per American Diabetes Association) and is under the care of a physician for the management of diabetes mellitus
- •Subject with glycosylated hemoglobin (HbA1c) ≤ 12%
- •Subject with at least one diabetic foot ulcer meets the following criteria at Screening
- •i. Located below knees; ii. Not healing for ≥ 4 weeks prior to Screening Visit despite appropriate care; iii. Ulcer size of ≥ 0.5 cm2 to ≤ 10 cm2 measured by the electronic measuring device following sharp debridement (if necessary) at Screening Visit and reconfirmed at Randomization Visit; iv. The largest ulcer will be selected as target ulcer. If ≥ 2 ulcers have the largest size, the one with the worst grade by Wagner Classification will be selected. If ≥ 2 ulcers have the largest size and grade, the one with longest duration will be selected; v. The target ulcer is classified as Grade 1 to Grade 2 according to Wagner Classification System for diabetic foot ulcer; vi. The target ulcer should be without clinical signs and symptoms of infection
- •Subject with adequate circulation to the affected lower limb, as demonstrated by at least one of the following criteria: i. Dorsum transcutaneous oximetry (TcPO2) ≥ 30 mmHg ii. Ankle brachial pressure index (ABPI) ≥ 0.7 iii. Absolute toe blood pressure \> 30 mmHg iv. Doppler ultrasonography showed \< 75% stenosis in the lower extremity arteries
- •Subject with adequate hepatic (ALT and AST ≤ 2 × ULN) and renal function (Serum creatinine ≤ 3 mg/dL)
- •Subject with adequate hematology function:
Exclusion Criteria
- •Clinical signs and symptoms of infection of target ulcer assessed by clinical evaluation.
- •The presence of infection is defined by ≥ 2 of the items presented as:
- •Local swelling or induration
- •Erythema \> 0.5 cm around wound
- •Local tenderness or pain
- •Local increased warmth
- •Purulent discharge
- •Subject with cellulitis or gangrene on the lower leg or foot with the target ulcer
- •Subject with active osteomyelitis, which requires systemic antibiotics. Systemic antibiotics must be complete or discontinued 1 week prior to Screening Visit.
- •With target ulcer size decreased or increased by at least 30% after receiving 2 weeks of standard-of-care for diabetic foot ulcer before Randomization visit
Arms & Interventions
High Dose Dosing Group
High Dose BB-101 topical solution will be applied on the target lower leg or foot ulcer once a for for 4 consecutive weeks.
Intervention: BB-101
Low Dose Dosing Group
Low Dose BB-101 topical solution will be applied on the target lower leg or foot ulcer once a for for 4 consecutive weeks.
Intervention: BB-101
Placebo Dosing Group
Placebo will be applied on the target lower leg or foot ulcer once a for for 4 consecutive weeks.
Intervention: BB-101
Outcomes
Primary Outcomes
Efficacy Evaluation
Time Frame: 4 weeks
Percent change in wound surface area (cm\^2) at each visit from baseline
Secondary Outcomes
- Safety Evaluation(6 weeks)
- Secondary Efficacy Evaluation(4 weeks)