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Six out of 10 patients with chronic wounds suffer from persistent wound pain. A multinational and multicenter randomized double-blind clinical investigation of 122 patients compared two moist wound healing dressings: a nonadhesive foam dressing with ibuprofen (62 patients randomized to Biatain Ibu Nonadhesive Coloplast A/S) and a nonadhesive foam without ibuprofen (60 patients to Biatain Non-Adhesive-comparator). Patients were recruited from September 2005 to April 2006. The ibuprofen foam was considered successful if the pain relief on a five-point Verbal Rating Scale was higher than the comparator without compromising safety including appropriate healing rate. Additional endpoints were change in persistent wound pain between dressing changes and pain at dressing change on days 1-5 (double blind) and days 43-47 (single blind). The primary response variable, persistent pain relief, was significantly higher in the ibuprofen-foam group, as compared with the comparator on day 1-5, with a quick onset of action (p<0.05). Wound pain intensity was significantly reduced with the ibuprofen foam during day 1-5 with 40% from baseline, compared with 30% with the comparator (p<0.001). At day 43-47, the patients in the ibuprofen-foam group had a significant (p<0.05) reemergence of persistent pain and pain at dressing change (p<0.05) when the active dressing was changed to the comparator. Wound healing was similar in the ibuprofen foam and comparator group. No difference in adverse events between the comparator and the ibuprofen foam with local sustained release of low-dose ibuprofen was observed in this study. It was generally found that women reported less pain intensity than men, and pain intensity decreased with increasing age. In addition, pain intensity increased with initial pain intensity and increasing wound size. This study has demonstrated that the ibuprofen-foam dressing provided pain relief and reduced pain intensity without compromising healing or other safety parameters.

Objective: Regenerative medicine products such as autologous platelet-rich plasma (autologous PRP) gel may speed up the process of healing. Clinical studies show promising results in the treatment of diabetic foot ulcers (DFUs), however there is lack of scientific evidence of autologous PRP effectiveness in treating leg ulcers of other aetiology. This study evaluates the effectiveness of autologous PRP gel in the treatment of hard-to-heal leg ulcers compared with existing conventional treatment. Method: A prospective, randomised controlled, open-labelled clinical trial was carried out between 2014 and 2018. An eight-week study protocol was chosen or until 100% wound re-epithelialisation was observed. Wound size reduction, granulation tissue formation, microbiological wound bed changes and safety were evaluated. Results: A total of 69 patients (35 in the autologous PRP group and 34 in the control group) were included in the study; 25.71% of the autologous PRP group and 17.64% of control group had ulcers completely re-epithelialised (p>0.05). Wound size reduction in the autologous PRP group was 52.35% and 33.36% in the control group (p=0.003). The autologous PRP group showed superiority over conventional treatment in wound bed coverage with granulation (p=0.001). However, more frequent wound contamination was observed at the end of treatment in the autologous PRP group (p=0.024). No severe adverse events were noted during the study. Both treatment methods were considered equally safe. Conclusion: Topical application of autologous PRP gel in leg ulcers of various aetiology show beneficial results in wound size reduction and induces the granulation tissue formation. However, it is associated with more frequent microbiological wound contamination.

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