Venous Leg Ulcers

Chronic wounds are wounds that do not heal properly over time and can significantly reduce quality of life. Common types include diabetic foot ulcers, venous leg ulcers, and arterial ulcers. Improving wound healing and speeding up skin regeneration (epithelialization) are important goals in the care of these patients. Dexpanthenol is a vitamin B5 derivative that supports skin repair and tissue regeneration. It is widely used in topical treatments, and injectable forms are approved for clinical use. However, the effects of subcutaneous (under the skin) dexpanthenol injections on chronic wound healing have not been sufficiently studied in clinical settings. The purpose of this study is to evaluate whether adding subcutaneous dexpanthenol injections to standard wound care improves wound healing compared with standard wound care alone. Adult patients with non-infected chronic wounds will be randomly assigned to one of two groups. One group will receive standard wound care only, while the other group will receive standard wound care plus subcutaneous dexpanthenol injections around the wound area. Wound healing will be assessed by measuring changes in wound size and the degree of skin epithelialization over time using standardized and objective methods. Safety will be monitored by recording local reactions at the injection site and any other adverse events during the study. The results of this study may provide preliminary clinical evidence on the effectiveness and safety of subcutaneous dexpanthenol as an additional treatment option for chronic wound management.

A Prospective, Multi-Center, Randomized Controlled Clinical Trial Evaluating NuShield® plus Standard of Care (SOC) versus Standard of Care (SOC) alone in the Management of Non-Healing Venous Leg Ulcers (VLUs). The study is a prospective, multi-center, open label, RCT designed to collect subject outcome data on NuShield plus Standard of Care vs Standard of Care alone for the management of VLUs.

The purpose of this study is to evaluate the efficacy of two dehydrated human umbilical cord-based medical devices, also defined as Cellular, Acellular, Matrix-like Products/skin substitutes, plus SOC versus SOC alone in achieving complete closure of hard-to-heal venous leg ulcers over 12 weeks using a modified platform trial design.

Background: Venous ulcers are skin lesions caused by impaired blood circulation. In Western countries, about 1% of the population is affected, and approximately 3% those over 80 years old. Venous leg ulcers tend to become chronic; a lesion is defined as chronic when it does not progress towards spontaneous healing. The treatment of these lesions inevitably involves long healing times, which results in increased healthcare costs. Moreover, venous leg ulcers have recurrence rates ranging from 18% to 28%. For this reason, it is important to support patients affected by or at risk of venous ulcers during their healing process or for prevention. Objectives: The primary objective of the study is to assess the superiority of the educational interventions to the standard therapeutic education, in improving the patient's/caregiver's self-efficacy, after 4 weeks, 3, 6 and 12 months from the educational intervention begin. The secondary objectives are to clinically assess the impact of the educational intervention in decreasing healing time and recurrence rates and in patients' well-being after 12 months of follow-up. Additionally, the Well-being of Wounds Inventory (WOW-I) questionnaire will be validated in its Italian version. Methods: the study is a two arm moncentric randomized-controlled trial. The participants will be randomly assigned into two groups. The control group will receive an educational intervention through a pamphlet, which represents the standard education received in the outpatient clinics involved in the study. The intervention group instead will receive an experimental educational intervention through video played specifically for this study. The socio-demografic, health and ulcer related factors will be collected and the questionnaires: venous leg ulcer knowledge (VLUK), Venous Leg Ulcer Self-Efficacy Tool (VeLUSET) and Well-being Of Wounds Inventory (WOW I) will be administered to the patients during the outpatient clinic visit, before the treatment and after 4 weeks, 3 and 6 months after the intervention. The study also includes a telephonic follow up at 12 months from the start carried out to assess if the patient's venous ulcer has healed or recurred.

The purpose of this study is to determine the between-arm difference in the proportion of subjects achieving complete closure of hard-to-heal venous leg ulcers (VLU) between Intact Fish Skin Graft plus standard of care (IFSG/SOC) versus standard of care alone (SOC) over 12 weeks.

The main purpose of this research study is to compare the proportion of wound closure in subjects that receive E-GRAFT™ with SOC versus FIBRACOL™ with SOC. Other research purposes include the following: * Rate of wound closure * Change in ulcer size over 12 weeks * Any adverse events or reactions (side effects) * Change in pain levels * Occurrence of infection