Efficacy and Safety Study of Soluble Beta-1,3/1,6-glucan (SBG) Versus Placebo in Chronic Diabetic Foot Ulcers

Biotec Pharmacon

Status and phase: Completed; Phase 3

Conditions: Diabetes; Diabetic Ulcer

Treatments: Drug: SBG; Drug: Placebo Comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT00804414

SBG-1-13

Details and patient eligibility

About

Evaluation of efficacy and safety of SBG vs placebo in the treatment of chronic diabetic foot ulcers.

Full description

The objective of this study is to evaluate efficacy and safety of soluble beta-1,3/1,6-glucan (SBG) on chronic diabetic foot ulcers.

Enrollment: 133 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with chronic diabetic foot ulcer

Exclusion criteria

• Insufficient nutritional status, renal function or diabetes control

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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133 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: SBG

2

Placebo Comparator group

Treatment:

Drug: Placebo Comparator