Objective Analysis of Heterologous Collagen Efficacy in Hard-To-Heal Venous Leg Ulcers

Maria Stefania Bertone, RN; Valentina Dini, MD; Paolo Romanelli, MD; Franco Rizzello, DI; Marco Romanelli, MD, PhD

     Abstract: Introduction. Collagen plays a major role in tissue repair and is a valid option for the treatment of chronic and acute wounds. Collagen speeds fibroblast deposition inside the extracellular matrix and stimulates angiogenesis, granulation tissue formation, and remodeling. Evaluation of the efficacy of wound treatment can be made by noninvasive, objective instrumental assessment. Materials and Methods. Forty-six patients with venous leg ulcers were enrolled into the study. The ulcers showed no clinical signs of healing over the course of 6 weeks despite standard treatment. Patients in group A were treated with a biological dressing made of heterologous collagen (Condress®, Abiogen Pharma, Italy) and with a standard treatment in group B. The duration of the treatment was 4 weeks. Chronic wounds were monitored by means of noninvasive assessment using a laser scanning system capable of performing 3D evaluation and color defragmentation. Results. The median increase in granulation tissue after 4 weeks of therapy was 65% in group A compared to 7% in group B (P < 0.001). A median reduction of 50% in relative ulcer area was observed in group A after 4 weeks of treatment, compared with 32% in group B (P < 0.05). Conclusion. This study objectively demonstrated that a heterologous collagen biological dressing induced granulation tissue in hard-to-heal venous leg ulcers better than standard treatment. The scanning system used to monitor lesions was not only fast, but was easy to use, and had good intra- and inter-observer reproducibility.

     Collagen plays a relevant role in cutaneous tissue repair and represents a valid therapeutic option when used as a bioactive advanced dressing in chronic wound management. It improves fibroblast deposition in the dermal matrix and stimulates angiogenesis, granulation tissue formation, and reepithelization.1 Fibroblasts mainly participate in the biosynthesis of collagen, which acts as a mold, precursor, plastic material, and cementing substance in the wound healing process. The treatment efficacy of collagen products requires precise monitoring on skin lesions using objective, accurate, and reproducible methods. More recently a new laser scanning system was developed that provides 3D wound assessment and acquires colorimetric information from cutaneous lesions.2

     The following is a report on the experience in using a heterologous equine collagen in hard-to-heal venous leg ulcers.

Materials and Methods

      Forty-six patients (31 women, 15 men) attending the outpatient leg ulcer clinic at the Department of Dermatology, University Hospital (Santa Chiara, Pisa, Italy) with hard-to-heal venous leg ulcers of more than 6 weeks’ duration were enrolled into the study. Patients entering the study showed clinical and instrumental signs of venous insufficiency complicated by lower leg ulceration (mean size 36.4 cm2). Exclusion criteria were: leg ulcers of purely arterial etiology, ulcers with clinical signs of infection, known sensitivity to the tested product, and the unwillingness of a patient to attend the clinic regularly for treatment and assessment. Before the study began, patients were required to complete a 3-week run-in period with standard treatment, including 4 layers of compression bandaging and moist wound healing. At the end of the run-in period, patients with a wound size reduction > 50% were excluded from the study. Informed consent was obtained from all patients and ethical approval was received from the local ethical committee before initiating the study.

     Patients were alternately allocated by 1 of the investigators into 2 groups: • Group A was treated with a sponge of heterologous collagen dressing (Condress®, Abiogen Pharma, Italy) and short stretch compression.


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