A randomised, double-blind, placebo-controlled study to assess the efficacy and safety of soluble beta-1,3/1,6-glucan (SBG) in chronic foot ulcers in patients with diabetes

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-003636-38-PL
• Date of registration: 09/09/2008
• Prospective Registration: Yes
• Primary sponsor: Biotec Pharmacon ASA
• Public title: A randomised, double-blind, placebo-controlled study to assess the efficacy and safety of soluble beta-1,3/1,6-glucan (SBG) in chronic foot ulcers in patients with diabetes
• Scientific title: A randomised, double-blind, placebo-controlled study to assess the efficacy and safety of soluble beta-1,3/1,6-glucan (SBG) in chronic foot ulcers in patients with diabetes
• Date of first enrolment: 05/11/2008
• Target sample size: 130
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-003636-38
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

Poland, Spain

Key inclusion & exclusion criteria

Inclusion criteria:
1. Type I or type II diabetes mellitus;
2. Age = 18 years;
3. At least one full thickness (i.e. extending into the subcutaneous tissue or beyond) ulcer of the foot at or below the malleoli that does not involve bone, tendons, ligaments, or muscle;
4. The target ulcer must have been present for at least 4 weeks prior to Visit 1, but not longer than 2 years;
5. Evidence of adequate perfusion on the affected extremity, as shown by an ankle:brachial pressure index (ABPI) = 0.7 and = 1.2, or the presence of two palpable pulses on the affected foot;
6. Estimated target ulcer surface area = 0.25 cm2 but = 10 cm2 as measured at Visit 1;
7. Female patients must have a negative serum pregnancy test prior to receiving study drug, unless they have had a hysterectomy, or have been post-menopausal for at least 1 year. Women with child bearing capacity must agree to use a medically accepted form of contraception throughout the study period;
8. Capability of understanding and giving written, voluntary informed consent;
9. Ability and willingness to attend the scheduled visits and comply with study procedures
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Pregnancy, breastfeeding or absence of adequate contraception for women with child bearing capacity;
2. Ulcer due to a non-diabetic aetiology;
3. Target ulcer on a foot affected by acute Charcot osteoarthropathy as determined by the clinical examination (new local pain, evidence of swelling and warmth);
4. Active osteomyelitis of the study foot;
5. Gangrene on any part of the foot with the target ulcer;
6. Presence of signs of clinically significant ulcer infection or cellulitis on the foot with the target ulcer on Visit 1;
7. Surgical procedure (other than debridement) on the foot with the target ulcer in the 28 days prior to Visit 1;
8. Poor nutritional status (albumin < 2.0 g/dL);
9. Uncontrolled diabetes (HbA1c ? 12%);
10. Chronic renal failure with calculated glomerular filtration rate (GFR)* < 30 mL/min;
11. Current alcohol or drug abuse;
12. Patient has vasculitis, severe rheumatoid arthritis, other collagen or vascular diseases or other medical conditions, outside of diabetes, known to impair wound healing;
13. Use of any topical treatments (e.g., topical antibiotics, enzymatic debridement) other than standard of care on the foot with the target ulcer at the time of enrolment, or received such therapies within 7 days prior to Visit 1;
14. Received dermal substitute, living skin equivalent or growth factor therapy on the foot with the target ulcer within 30 days prior to Visit 1;
15. Treatment with systemic corticosteroids, immunosuppressive or chemotherapeutic agents or radiotherapy on the study foot within 30 days prior to Visit 1, or likelihood to receive any of these therapies during study participation;
16. Known or suspected hypersensitivity to any study product components;
17. Participation in other clinical trials in the preceding 28 days



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

chronic foot ulcers in patients with diabetes
MedDRA version: 9.1 Level: LLT Classification code 10012664 Term: Diabetic foot ulcer

Intervention(s)

Product Name: Soluble Beta-1,3/1,6-glucan
Pharmaceutical Form: Cutaneous solution
CAS Number: 53238-80-5
Current Sponsor code: SBG
Other descriptive name: ß(1?3)/(1?6)-D-glucan
Concentration unit: % percent
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Cutaneous solution
Route of administration of the placebo: Topical use (Noncurrent)

Primary Outcome(s)

Main Objective: To compare the proportion of patients who have healing of their target ulcer within 8 weeks after starting topical treatment with SBG or placebo.

Primary end point(s): Proportion of patients with target ulcers that heal within 8 weeks

Secondary Objective: To compare topically applied SBG and placebo with respect to:
I. The proportion of patients who have healing of their target ulcer within 12 weeks after starting treatment with study medication;
II. The time from the start of treatment until healing of the target ulcer;
II. The percent change in area of the target ulcer;
IV. The recurrence of healed target ulcers within 12 weeks after healing;
V. Safety of topically applied SBG

Secondary ID(s)

SBG-1-13

2008-003636-38-ES