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
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
Treatments tested in this trial
- BB-101
Treatment groups
96 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov