Patrícia Michelassi Carrinho1, Dora Inés Kozusny Andreani1, Vislaine de Aguiar Morete2, Shizumi Iseri2, Ricardo Scarparo Navarro3, Antonio Balbin Villaverde4,5. 1. 1 Biomedical Engineering Program, Brazil University , Fernandópolis, Brazil . 2. 2 Faculty of Medicine, Brazil University , Fernandópolis, Brazil . 3. 3 Biomedical Engineering and Bioengineering Programs, Brazil University , São Paulo, Brazil. 4. 4 Biomedical Engineering Center, Anhembi Morumbi University (UAM) , São Paulo, Brazil . 5. 5 Center of Innovation, Technology and Education-CITÉ , São José dos Campos, Brazil .
Abstract
BACKGROUND: Diabetes Mellitus is a chronic disease that can lead to lower-limb ulceration. The photodynamic therapy (PDT) is based on light interaction with a photosensitizer capable to promote bacterial death and acceleration of wound healing. OBJECTIVE: This study aims to accomplish a macroscopic morphometry evaluation on diabetic ulcer area in humans that were under PDT. MATERIALS AND METHODS: A clinical study was conducted by convenience sample, experimental, controlled, and blinded, composed of 12 patients of both sexes with diabetic ulcers in lower limbs that were divided into two groups, control (n = 6) and PDT (n = 6). They were all treated with collagenase/chloramphenicol during the experimental period, in which six of them had received PDT with Methylene Blue dye (0.01%) associated with laser therapy (660 nm, 30 mW, 8 sec, 6 J/cm2, beam area of 0.04 mm2), three times per week, totaling 10 sessions. Ulcer areas were analyzed by their nominal area and photographed for analysis through the ImageJ® software. Then, the Ulcer Healing Index and the wound area reduction were calculated for both groups. RESULTS: Data from the UHI and wound area reduction parameters show that there is a statistically significant difference (p < 0.05) between the control group and PDT group, with the PDT group showing a greater reduction of the diabetic ulcer area than the control group. In the ImageJ software area analysis, both patient groups presented significant differences (p < 0.05) between pre and post-treatment in relation to lesion reduction area, the PDT being better. CONCLUSIONS: Results show that PDT accelerates the closure of ulcer wounds and to evaluate the wound area, different measurement methods can be used to follow-up the tissue repair process.
RCT Entities:
BACKGROUND:Diabetes Mellitus is a chronic disease that can lead to lower-limb ulceration. The photodynamic therapy (PDT) is based on light interaction with a photosensitizer capable to promote bacterial death and acceleration of wound healing. OBJECTIVE: This study aims to accomplish a macroscopic morphometry evaluation on diabetic ulcer area in humans that were under PDT. MATERIALS AND METHODS: A clinical study was conducted by convenience sample, experimental, controlled, and blinded, composed of 12 patients of both sexes with diabetic ulcers in lower limbs that were divided into two groups, control (n = 6) and PDT (n = 6). They were all treated with collagenase/chloramphenicol during the experimental period, in which six of them had received PDT with Methylene Blue dye (0.01%) associated with laser therapy (660 nm, 30 mW, 8 sec, 6 J/cm2, beam area of 0.04 mm2), three times per week, totaling 10 sessions. Ulcer areas were analyzed by their nominal area and photographed for analysis through the ImageJ® software. Then, the Ulcer Healing Index and the wound area reduction were calculated for both groups. RESULTS: Data from the UHI and wound area reduction parameters show that there is a statistically significant difference (p < 0.05) between the control group and PDT group, with the PDT group showing a greater reduction of the diabetic ulcer area than the control group. In the ImageJ software area analysis, both patient groups presented significant differences (p < 0.05) between pre and post-treatment in relation to lesion reduction area, the PDT being better. CONCLUSIONS: Results show that PDT accelerates the closure of ulcer wounds and to evaluate the wound area, different measurement methods can be used to follow-up the tissue repair process.