Efficacy of Soluble Beta-1,3/1,6-Glucan Compared to Placebo on Chronic Leg Ulcers in Diabetes Patients

NCT00288392 | Completed Phase 2

• 1 other identifier: SBG-1-11
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the efficacy of soluble beta-1,3/1,6-glucan compared to placebo on the healing of chronic leg ulcers in diabetes patients. Hypothesis: Through its ability to activate tissue macrophages and counteract diabetes-associated defects in macrophages, the soluble beta-1,3/1,6-glucan will promote the healing of leg ulcers in diabetic patients.

Conditions

Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• - Time to healing

Secondary Outcomes (4)

• Number of patients with complete healing of treated ulcers after 12 weeks of treatment

• Percentage reduction in ulcer area of treated ulcers after 12 weeks of treatment

• Percentage weekly reduction in ulcer area in treated ulcers

• Safety

Interventions

Soluble beta-1,3/1,6-glucan DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 or Type 2 diabetes mellitus
• Age\>= 18 years
• Study wound is a Wagner Grade 1 partial thickness or Grade 2 full thickness lesion but without exposed tendon, joint, or bones
• Study wound located on the foot or lower leg
• Study wound must have been present for at least 4 weeks prior to Day 0 but not longer than 2 years
• Adequate circulation to the foot, evidenced by a palpable pulse on the study foot
• Study wound \> 1.0cm2 but \< 20.0cm2
• Written informed consent

You may not qualify if:

• Pregnancy, lactation or absence of adequate contraception for fertile women
• Ankle/Brachial Index \< 0.7
• Severe malnutrition
• Clinical evidence of gangrene on any part of the foot with the study wound
• Active or extensive cellulitis extending more than 1 cm beyond wound margin and/or presence of cellulitis with purulent discharge on day 0
• One or more medical condition(s) that in the opinion of the investigator would make the patient an inappropriate candidate for the study
• Active osteomyelitis of the foot with the study wound
• Necrotic toes on the foot with the study wound
• Surgical procedure (other than debridement) on the foot with the study wound the last 21 days prior to screening
• Study wound over a Charcot's joint
• Evidence of deep tissue infection of the study wound at day 0
• Non-study wound on the study foot that is located within 5.0cm from the study wound at day 0
• Random blood sugar reading \> 450 mg/dL
• Alcohol or drug abuse
• Participation in other clinical studies in the last 4 weeks

Sponsors & Collaborators

• Biotec Pharmacon ASA: lead

Study Sites (2)

Municipal Healthcare Institution 1st City Clinical Hospital

Arkhangelsk, 163061, Russia

Location

St. Petersburg State Institution Saint Martyr Elezabeth Hospital

Saint Petersburg, 195257, Russia

Location

Related Publications (1)

• Zykova SN, Balandina KA, Vorokhobina NV, Kuznetsova AV, Engstad R, Zykova TA. Macrophage stimulating agent soluble yeast beta-1,3/1,6-glucan as a topical treatment of diabetic foot and leg ulcers: A randomized, double blind, placebo-controlled phase II study. J Diabetes Investig. 2014 Jul;5(4):392-9. doi: 10.1111/jdi.12165. Epub 2013 Dec 2.

  PMID: 25411598 DERIVED

MeSH Terms

Conditions

Foot Ulcer

Condition Hierarchy (Ancestors)

Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Leg Ulcer; Skin Ulcer

Study Officials

• Tatyana Zykova, Dr.med.

  Municipal Healthcare Institution 1st City Hospital, Department of Endocrinology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 7, 2006
• First Posted: February 8, 2006
• Study Start: June 1, 2005
• Study Completion: September 1, 2006
• Last Updated: October 18, 2006

Record last verified: 2006-05

Locations

RU (2)