Trial on the Efficacy of Prontosan Wound Irrigation Solution and Prontosan Wound Gel
Condition: Venous Leg Ulcer
MeSH terms: Varicose Ulcer; Leg Ulcer
Intervention: Prontosan Wound Irrigation Solution and Prontosan Wound Gel; Normal Saline and Placebo Gel
Intervention description: The treatment procedures (after a 1 week run-in) include:
Cleansing the wound bed, at dressing change, with Prontosan® Wound Irrigation Solution or saline solution; a sterile gauze dressing impregnated with the Prontosan® or saline solution, depending on randomisation, will be placed on the wound in the form of a moist compress and removed after 15 minutes; the wound will be sparingly covered with Prontosan® Wound Gel or inactive gel, depending on randomisation
Secondary dressing to be a semi occlusive dressing
Secure the dressing to the wound with tubifast and short stretch compression system Dressings will be changed and the treatment procedure will be repeated every 3 days (+/- 1 day) when clinical, microbiological, planimetry and photographic assessments will be made. The randomised solution will also be used for removal of the dressing from the wound at the start of dressing change.; The treatment procedures (after a 1 week run-in) include:
Cleansing the wound bed, at dressing change, with Prontosan® Wound Irrigation Solution or saline solution; a sterile gauze dressing impregnated with the Prontosan® or saline solution, depending on randomisation, will be placed on the wound in the form of a moist compress and removed after 15 minutes; the wound will be sparingly covered with Prontosan® Wound Gel or inactive gel, depending on randomisation
Secondary dressing to be a semi occlusive dressing
Secure the dressing to the wound with tubifast and short stretch compression system
Dressings will be changed and the treatment procedure will be repeated every 3 days (+/- 1 day) when clinical, microbiological, planimetry and photographic assessments will be made. The randomised solution will also be used for removal of the dressing from the wound at the start of dressing change.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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 saline irrigation solution and inactive gel by showing a reduction in size over a
      12 week period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 Criteria:

          -  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%)