CompletedPhase 1

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

Taiwan14 participantsStarted 2018-03-28

Plain-language summary

This is a randomized, double-blind, placebo-controlled, sequential dose escalation study in diabetic subjects with a diabetic lower leg or foot ulcer. All subjects will receive standard-of-care ulcer treatment from screening through the last study visit.

Who can participate

Age range20 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. located below knees,
✓. Area of 0.5 - 20.0 cm\^2 following sharp debridement , as measured at Visit 1 and confirmed at Visit 2,
✓. Extending through the epidermis and dermis and may have reached bone, tendon or joint capsule (Grade 1 to grade 2 according to Wagner Classification System for diabetic foot ulcer),
✓. Present for ≥4 weeks prior to Visit 1 despite appropriate care, and
✓. Ulcer without clinical signs and symptoms of infection.

Exclusion criteria

✕. QTc ≥450 ms in male subject or ≥460 ms in female subject at screening
✕. Significant ST-segment-T wave (ST-T) changes or left bundle branch block (LBBB)
✕. Has a history of, or concurrent congestive heart failure (CHF) defined by New York Heart Association (NYHA) Classes III or IV.
✕. Myocardial infarction (MI), unstable angina, percutaneous coronary intervention, or coronary artery bypass graft surgery within 12 weeks prior to Screening. Subjects with adequately treated stable angina, per physician investigator's assessment, may be included.

What they're measuring

Incidence and severity of local reactions

Timeframe: 6 weeks

Incidence and severity of adverse events

Timeframe: 6 weeks

Incidence of clinical laboratory abnormalities

Timeframe: 6 weeks

Change from baseline in ECG

Timeframe: 6 weeks

Change from baseline in blood pressure

Timeframe: 6 weeks

Change from baseline in heart rate

Timeframe: 6 weeks

Change from baseline in body temperature

Timeframe: 6 weeks

Presence of anti-BB-101 antibodies

Timeframe: 6 weeks

Trial details

NCT IDNCT03888053

SponsorBlue Blood Biotech Corp.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-12-01

View on ClinicalTrials.gov More Diabetic Foot Ulcer trials

Who can participate

Age range20 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. located below knees,
✓. Area of 0.5 - 20.0 cm\^2 following sharp debridement , as measured at Visit 1 and confirmed at Visit 2,
✓. Extending through the epidermis and dermis and may have reached bone, tendon or joint capsule (Grade 1 to grade 2 according to Wagner Classification System for diabetic foot ulcer),
✓. Present for ≥4 weeks prior to Visit 1 despite appropriate care, and
✓. Ulcer without clinical signs and symptoms of infection.

Exclusion criteria

✕. QTc ≥450 ms in male subject or ≥460 ms in female subject at screening
✕. Significant ST-segment-T wave (ST-T) changes or left bundle branch block (LBBB)
✕. Has a history of, or concurrent congestive heart failure (CHF) defined by New York Heart Association (NYHA) Classes III or IV.
✕. Myocardial infarction (MI), unstable angina, percutaneous coronary intervention, or coronary artery bypass graft surgery within 12 weeks prior to Screening. Subjects with adequately treated stable angina, per physician investigator's assessment, may be included.

What they're measuring

Incidence and severity of local reactions

Timeframe: 6 weeks

Incidence and severity of adverse events

Timeframe: 6 weeks

Incidence of clinical laboratory abnormalities

Timeframe: 6 weeks

Change from baseline in ECG

Timeframe: 6 weeks

Change from baseline in blood pressure

Timeframe: 6 weeks

Change from baseline in heart rate

Timeframe: 6 weeks

Change from baseline in body temperature

Timeframe: 6 weeks

Presence of anti-BB-101 antibodies

Timeframe: 6 weeks