BB-101 for the Treatment of Diabetic Lower Leg and Foot Ulcers

ConditionDiabetic Foot Ulcer

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age20+

SponsorBlue Blood Biotech Corp.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Clinical signs and symptoms of infection of target ulcer assessed by clinical evaluation.

Local swelling or induration

Erythema > 0.5 cm around wound

Local tenderness or pain

Trial design

Design model

Parallel

Treatments tested in this trial

BB-101
Biological/Vaccine
Subjects will be randomized to receive BB-101 or placebo, and expected 32 subjects for each arm.

Treatment groups

96 Participants

are divided into 3 treatment groups

Group A: High Dose Dosing GroupActive comparator 1 intervention

Group B: Low Dose Dosing GroupActive comparator 1 intervention

Group C: Placebo Dosing GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Efficacy Evaluation

Percent change in wound surface area (cm\^2) at each visit from baseline

Time frame

4 weeks

Secondary outcomes

Secondary Efficacy Evaluation

Incidence of complete wound closure and change in Wagner Scale

Time frame

4 weeks

Safety Evaluation

To evaluate the Laboratory data, ECG examination results, physical examinations and vital signs changes from baseline, and AE incidences

Time frame

6 weeks

Other outcomes

Exploratory Objectives

Percent surface area of wound covered by granulation tissue

Time frame

6 weeks

Exploratory Objectives

Change of ulcer conditions

Time frame

6 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Blue Blood Biotech Corp.

Lead sponsor

Source ClinicalTrials.gov

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