Soluble Beta-glucan (SBG) as Treatment for Diabetic Foot Ulcers

Biotec Pharmacon

Status and phase

Completed

Phase 3

Conditions

Chronic Diabetic Foot Ulcers

Treatments

Drug: Soluble beta-glucan (SBG)

Drug: Placebo comparator

Study type

Interventional

Funder types

Industry

Identifiers

NCT00632008

SBG-1-12

Details and patient eligibility

About

The purpose of this study is to determine whether the application of soluble beta-glucan (SBG) onto diabetic foot ulcers improves the healing of the ulcers.

Enrollment

122 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Type 1 or Type 2 diabetes mellitus
Age ≥ 18 years
One or more full-thickness ulcers at or below the level of the malleoli, which do not extend to tendon, joint, or bone
The ulcer (or index ulcer, if appropriate) must have been present for at least 4 weeks prior to Day 0 but not longer than 2 years
Ankle:brachial pressure index (ABPI) >0.7, or the presence of two palpable pulses on the affected foot
Ulcer area >25 mm2 but <500 mm2
Written informed consent

Exclusion criteria

Pregnancy, lactation or absence of adequate contraception for women with child bearing capacity
ABPI < 0.7
Serum albumin < 2.0 g/dL
Gangrene on any part of the foot with the study ulcer
Presence of signs of clinically significant foot infection on Day 0
Chronic renal failure with calculated GFR <30 ml/min
Surgical procedure (other than debridement) on the foot with the study ulcer in the 28 days prior to Day 0
HbA1c 12% or more
Current alcohol or drug abuse
Participation in other studies in the preceding 28 days
An ulcer on a foot affected by acute Charcot osteoarthropathy