Status:
COMPLETED
Trial on the Efficacy of Prontosan Wound Irrigation Solution and Prontosan Wound Gel
Lead Sponsor:
B. Braun Ltd. Centre of Excellence Infection Control
Conditions:
Venous Leg Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The primary objective of the study is to evaluate the efficacy of Prontosan® Wound Irrigation Solution and Prontosan® Wound Gel in the treatment of hard-to heal venous leg ulcers compared to control s...
Detailed Description
SUMMARY Sponsor: B. BRAUN Medical AG Trade name: Prontosan® Wound Irrigation Solution Prontosan® Wound Gel Active substance: Polihexanide (0.1%) Betaine (0.1%) Study Duration (per patient): 13 we...
Eligibility Criteria
Inclusion
- Males and females aged \> 18 who are able to give informed consent
- Patients with a chronic venous leg ulcer at any location below the knee joint (CVI grade C6 according to CEAP classification = trophic lesions and open ulcer)
- Venous leg ulcer present for ≥4 weeks
- Surface area of the target ulcer ≥2cm2 and \<100cm2 with the largest length not being \>10cm
- ABPI ≥ 0.7
Exclusion
- Age below 18 years
- Females of child bearing potential who are not willing to use a method of highly effective contraception during the entire study
- Pregnant or breast feeding women
- Signs and symptoms of clinical infection, or current use of antiseptics or antibiotics
- Involvement in other trials within the past 1 month
- Sensitivity to any of the components of Prontosan® or dressing material
- Intolerance to compression therapy
- Active osteomyelitis in the ulceration area
- Active rheumatoid or collagen disease of blood vessels treated with corticosteroids
- Chronic diseases that could impact the course of the study (malicious cancer, TB, AIDS, mental illnesses)
- Plasma protein below 4 g/dl
- Anaemia: haemoglobin below 10 g/dl
- Poorly controlled Diabetes (HBA1C \> 12%)
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01153633
Start Date
October 1 2009
End Date
October 1 2011
Last Update
April 1 2014
Active Locations (1)
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1
Cardiff University, Department of Wound Healing
Cardiff, Wales, United Kingdom, CF14 4XN