Phase 4
Completed N=34
Trial on the Efficacy of Prontosan Wound Irrigation Solution and Prontosan Wound Gel
Source: ClinicalTrials.gov NCT01153633 ↗Enrolled (actual)
34
Serious AEs
2.9%
Results posted
Apr 2014
Primary outcomePrimary: Percent Change of Wound Size From Baseline to Last Visit — -64.98; -42.78 percentage change in wound size (cm2) — p=0.2317
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change of Wound Size From Baseline to Last Visit |
-64.98; -42.78 | 0.2317 |
| PRIMARY Healing of Target Ulcer atV6/EOS |
8; 5 | 0.4905 |
| PRIMARY Absolute Change of Target Ulcer From Baseline to Last Visit |
-3.00; -3.01 | 0.9945 |
| SECONDARY Number of Different Microganisms at V6/EoS |
0.8; 1.0 | — |
| SECONDARY Pain |
-8.9; -12.8 | — |
| SECONDARY Condition of Wound Bed |
7.1; -1.5 | — |
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 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%)
Data sourced from ClinicalTrials.gov (NCT01153633). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.