Estudio aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia y seguridad de beta-1,3/1,6- glucano soluble (SBG) en úlceras crónicas del pie en pacientes con diabetes.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.
- Conditions
- Úlceras crónicas del pie en pacientes con diabetesChronic foot ulcers in patients with diabetesMedDRA version: 9.1Level: LLTClassification code 10012664Term: Diabetic foot ulcer
- Registration Number
- EUCTR2008-003636-38-ES
- Lead Sponsor
- Biotec Pharmacon ASA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 130
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method