Healing Process, Pain, and Health-Related Quality of Life in Patients with Venous Leg Ulcers Treated with Fish Collagen Gel: A 12-Week Randomized Single-Center Study

Abstract

The aim of the study was to assess the effectiveness of fish skin collagen and its impact on healing, pain intensity, and quality of life in patients with venous leg ulcers (VLUs). This study included 100 adults with VLUs. Eligible patients were randomized to either tropocollagen gel treatment (group A, n = 47) or placebo alone (group B, n = 45). We applied the gel to the periwound skin for 12 weeks. All groups received standard wound care, including class 2 compression therapy and wound hygiene procedures. We assessed the healing rate (cm2/week) and quality of life (QoL) using the Skindex-29 and CIVIQ scales. In group A, more ulcers healed, and the healing rate was faster. In both study groups, patients showed a significant improvement in quality of life after the intervention, but there was a greater improvement in the tropocollagen group. In group A, the greatest improvement was related to physical symptoms and the pain dimension. This study showed that the application of fish collagen gel to the periwound skin improves the healing process and QoL in patients with VLUs. The 12-week treatment with collagen reduced the severity of physical complaints, pain, and local skin symptoms, which determined the quality of life in patients with VLUs to the greatest extent.

Influence of pain on the quality of life in patients with venous ulcers: Cross-sectional association and correlation study in a brazilian primary health care lesions treatment center

“…Regarding the sociodemographic profile, the participants in our sample were mostly woman, aged 60 years or older (considered older people in Brazil), of low income and education, and did not have professional activity. These data are similar to other profiles found in the literature [ 5 , 21 , 22 ]. Authors explained that VU are more common in women, since in this public there is greater overload in the venous network, which presupposes fluid retention and greater difficulties in venous return when compared to men [ 1 ].…”

Clinical Efficacy of Hyaluronic Acid with Iodine in Hard-to-Heal Wounds

“…Several studies observed a complete healing rate of VLU of 23–35% after 12 weeks of standard treatment [ 28 , 29 , 30 , 31 , 32 ]. We reached 55.6% completely healed wounds, which indicates support for wound healing compared to standard therapies ( Table 3 ).…”

Correlation between Generic and Disease-Specific Quality of Life Questionnaires in Patients with Venous Ulcerations: A Cross-Sectional Study Carried out in a Primary Health Care Setting in Brazil

“…Nevertheless, when we performed the analysis, considering the subcategories of sociodemographic variables, we noticed that this correlation lost strength and statistical significance among participants under 60 years of age. Authors have pointed out that pain is present in most people with VU and is related to local hypoxia triggered by poor circulation in the affected limb, which can lead to impairments in the mobility of the individuals and their willingness to perform homework and social interaction activities [ 24 , 25 ]. It is important to highlight that in other QoL scales used in people with VU, as well as in the SF-36, pain is one of the aspects evaluated individually; this is the case for the Charing Cross Venous Ulcer Questionnaire, Venous Leg Ulcer Quality of Life (VLU-QoL), Sheffield Preference-based Venous Ulcer Questionnaire (SPVU-5D), and the EQ-5D-5L [ 10 ].…”