Extracorporeal shockwave therapy in the treatment of chronic diabetic foot ulcers: a prospective randomised trial.

OBJECTIVE: To investigate the efficacy of extracorporeal shockwave therapy (ESWT) on healing chronic diabetic foot ulcers (DFU). METHOD: Patients with chronic DFUs were randomised (1:1) to receive a series of six ESWT treatments over 3 weeks in combination with standard care or standard care alone. ESWT was performed on DFUs using 250 shocks/cm2 and 500 shocks on arterial beds supplying the ulcer location. RESULTS: We recruited 23 patients, 11 in the intervention group and 12 in the control. Transcutaneous oxygen tension was significantly increased in patients treated with ESWT compared with those receiving standard care alone at 3 weeks (p=0.044). Ulcer area reduction was 34.5% in the intervention group versus 5.6% in the control group at 7 weeks (p=0.387). Within-group analysis revealed a significant reduction of ulcer area in the intervention group (p<0.01), while healing was not demonstrated in the control group (p>0.05) (data tested for trend). CONCLUSION: This randomised study indicates a potential beneficial effect of ESWT on ulcer healing as well as tissue oxygenation. Owing to weaknesses of the study and the fact that ulcer healing was not significantly improved in the intervention group compared with the control group, a larger randomised trial with blinded design is suggested.

A qualitative study of the key factors in implementing telemedical monitoring of diabetic foot ulcer patients.

INTRODUCTION: The implementation of telemedicine often introduces major organizational changes in the affected healthcare sector. The objective of this study was to examine the organizational changes through the perception of the healthcare professionals regarding the implementation of a telemedical intervention. We posed the following research question: What are the key organizational factors in the implementation of telemedicine in wound care? METHODS: In connection with a randomized controlled trial of telemedical intervention for patients with diabetic foot ulcers in the region of Southern Denmark, we conducted an organizational analysis. The trial was designed as a multidisciplinary assessment of outcomes using the Model of ASsessment of Telemedicine (MAST). We conducted eight semi-structured interviews including individual interviews with leaders, and an IT specialist as well as focus group interviews with the clinical staff. A qualitative data analysis of the interviews was performed in order to analyze the healthcare professionals and leaders perception of the organizational changes caused by the implementation of the intervention. RESULTS: The telemedical setup enhanced confidence among collaborators and improved the wound care skills of the visiting nurses from the municipality. The effect was related to the direct communication between visiting nurses and specialist doctors. Focus on the training of the visiting nurses was highlighted as a key factor in the success to securing implementation. Concerns regarding lack of multidisciplinary wound care teams, patient responsibility and lack of patient interaction with the physician were raised. Furthermore, the need for clinical guidelines in future implementation was underlined. CONCLUSIONS: Several influential factors were demonstrated in the analysis including visiting nurses wound care training, focus on management, economy, periods with absence from work and clinical care. However, the technology used here could provide an additional option to offer patients after an individual assessment of their health condition.

Validation of a new imaging device for telemedical ulcer monitoring.

PURPOSE: To clarify whether a new portable imaging device (PID) providing 3D images for telemedical use constitutes a more correct expression of the clinical situation compared to standard telemedical equipment in this case iPhone 4s. METHOD: We investigated intra- and interindividual variability between the new portable camera and the iPhone images vs. clinical assessment as the 'gold standard'. The study included 36 foot ulcers. Four specialists rated the ulcers and filled out a questionnaire, which formed the basis of the evaluation. RESULTS: We found fair to very good intra-rater agreement for the new PID and iPhone, respectively. The gold standard was evaluated by assessing the ulcer twice by two different specialists. Kappa values were moderate to very good with respect to inter-rater agreement except for two variables. The agreement between standard and new equipment compared to the gold standard showed highest agreement with the new PID. CONCLUSION: The new PID is more in accordance with the clinical assessment compared to standard images. It opens for the possibility of using more advanced techniques in a telemedical approach to ulcer treatment and care, including volume measurements.