scholarly journals Foot thermometry with mHeath-based supplementation to prevent diabetic foot ulcers: A randomized controlled trial

2020 ◽  
Vol 5 ◽  
pp. 23
Author(s):  
Maria Lazo-Porras ◽  
Antonio Bernabe-Ortiz ◽  
Alvaro Taype-Rondan ◽  
Robert H. Gilman ◽  
German Malaga ◽  
...  
Keyword(s):  
Diabetic Foot ◽  
Patient Adherence ◽  
Controlled Trial ◽  
Risk Groups ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Foot Care ◽  
Care Groups ◽  
History Of ◽  
Control Instruction

Background: Three previous clinical trials have found that thermometry use reduced diabetic foot ulcers (DFUs) incidence four- to ten-fold among individuals with diabetes at high-risk of developing a DFU. However, these benefits depend on patient adherence to self-assessment. Therefore, novel approaches to improve self-management thermometry adherence are needed. Our objective was to compare incidence of DFUs in the thermometry plus mobile health (mHealth) reminders intervention arm vs. thermometry-only control arm. Methods: We conducted a randomized trial, enrolling adults with type 2 diabetes mellitus at risk of foot ulcers (risk groups 2 or 3) but without foot ulcers at the time of recruitment and allocating them to control (instruction to use a liquid crystal-based foot thermometer daily) or intervention (same instruction supplemented with text and voice messages with reminders to use the device and messages to promote foot care) groups and followed for 18 months. The primary outcome was time to occurrence of DFU. A process evaluation was also conducted. Results: A total of 172 patients (63% women, mean age 61 years) were enrolled; 86 to each study group. More patients enrolled in the intervention arm had a history of DFU (66% vs. 48%). Follow-up for the primary endpoint was complete for 158 of 172 participants (92%). DFU cumulative incidence was 24% (19 of 79) in the intervention arm and 11% (9 of 79) in the control arm. After adjusting for history of foot ulceration and study site, the Hazard Ratio (HR) for DFU was 1.44 (95% CI 0.65, 3.22). Adherence to ≥80% of daily temperature measurements was 87% (103 of 118) among the study participants who returned the logbook, with no difference between the intervention and control arms. Conclusions: This trial contributes to the evidence about the value of mHealth in preventing diabetes foot ulcers. Trial registration: ClinicalTrials.gov NCT02373592 (27/02/2015)

scholarly journals Foot thermometry with mHeath-based supplementation to prevent diabetic foot ulcers: A randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Maria Lazo-Porras ◽  
Antonio Bernabe-Ortiz ◽  
Alvaro Taype-Rondan ◽  
Robert H. Gilman ◽  
German Malaga ◽  
...  
Keyword(s):  
Diabetic Foot ◽  
Controlled Trial ◽  
Risk Groups ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Foot Care ◽  
History Of ◽  
Control Instruction ◽  
Study Participants ◽  
And Control

BACKGROUND Thermometry monitoring has proven to reduce the occurrence of diabetic foot ulcers (DFU). mHealth may contribute to enhance adherence to this effective intervention. OBJECTIVE Our objective was to compare incidence of DFU in the thermometry plus mHealth reminders intervention arm vs. thermometry-only control arm. METHODS We conducted a randomized trial enrolling adults with type 2 diabetes mellitus with foot-at-risk (risk groups 2 or 3) without foot ulcers and allocating them to control (instruction to use a liquid crystal-based foot thermometer daily) or to intervention (same instruction supplemented with text and voice messages with reminders to use the device and messages to promote foot care) and followed for 18 months. The primary outcome was time to occurrence of DFU. A process evaluation was also conducted. RESULTS A total of 172 patients (63% women, mean age 61 years) were enrolled, 86 to each study group. More patients enrolled in the intervention arm had a history of DFU (66% vs. 48%). Follow-up for the primary endpoint was complete for 158 of 172 participants (92%). DFU cumulative incidence was 24% (19 of 79) in the intervention arm and 11% (9 of 79) in the control arm. After adjusting for history of foot ulceration and study site, the HR for DFU was 1.44 (95% CI 0.65, 3.22). Adherence to ≥80% of daily temperature measurements was 87% (103 of 118) among the study participants that returned the logbook, without difference between intervention and control arm. CONCLUSIONS This trial contributes to the evidence about the value of mHealth to prevent diabetes foot ulcers. CLINICALTRIAL Clinical trials, NCT02373592. Registered 27 February 2015, https://clinicaltrials.gov/ct2/show/NCT02373592

scholarly journals Foot thermometry with mHeath-based supplementation to prevent diabetic foot ulcers: A randomized controlled trial

2020 ◽  
Vol 5 ◽  
pp. 23 ◽  
Author(s):  
Maria Lazo-Porras ◽  
Antonio Bernabe-Ortiz ◽  
Alvaro Taype-Rondan ◽  
Robert H. Gilman ◽  
German Malaga ◽  
...  
Keyword(s):  
Low Income ◽  
Diabetic Foot ◽  
Controlled Trial ◽  
Intervention Group ◽  
Risk Groups ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Foot Care ◽  
Foot Ulceration ◽  
History Of

Background: Novel approaches to reduce diabetic foot ulcers (DFU) in low- and middle-income countries are needed. Our objective was to compare incidence of DFUs in the thermometry plus mobile health (mHealth) reminders (intervention) vs. thermometry-only (control). Methods: We conducted a randomized trial enrolling adults with type 2 diabetes mellitus at risk of foot ulcers (risk groups 2 or 3) but without foot ulcers at the time of recruitment, and allocating them to control (instruction to use a liquid crystal-based foot thermometer daily) or intervention (same instruction supplemented with text and voice messages with reminders to use the device and messages to promote foot care) groups, and followed for 18 months. The primary outcome was time to occurrence of DFU. A process evaluation was also conducted. Results: A total of 172 patients (63% women, mean age 61 years) were enrolled; 86 to each study group. More patients enrolled in the intervention arm had a history of previous DFU (66% vs. 48%). Follow-up for the primary endpoint was complete for 158 of 172 participants (92%). Adherence to ≥80% of daily temperature measurements was 87% (103 of 118) among the study participants who returned the logbook. DFU cumulative incidence was 24% (19 of 79) in the intervention arm and 11% (9 of 79) in the control arm. After adjusting for history of foot ulceration and study site, the hazard ratio (HR) for DFU was 1.44 (95% CI 0.65, 3.22). Conclusions: In our study, conducted in a low-income setting, the addition of mHealth to foot thermometry was not effective in reducing foot ulceration. Importantly, there was a higher rate of previous DFU in the intervention group, the adherence to thermometry was high, and the expected rates of DFU used in our sample size calculations were not met. Trial registration: ClinicalTrials.gov NCT02373592 (27/02/2015)

Differences in foot care practice between participants at risk for and with diabetic foot ulcers (DFUs) in community

2020 ◽  
Vol 30 ◽  
pp. 144-148
Author(s):  
Uswatun Hasanah ◽  
Saldy Yusuf ◽  
Rini Rachmawaty ◽  
Musdalifah Mukhtar ◽  
Serlina Sandi
Keyword(s):  
At Risk ◽  
Diabetic Foot ◽  
Foot Ulcers ◽  
Care Practice ◽  
Diabetic Foot Ulcers ◽  
Foot Care

scholarly journals Cellular Proliferation, Dermal Repair, and Microbiological Effectiveness of Ultrasound-Assisted Wound Debridement (UAW) Versus Standard Wound Treatment in Complicated Diabetic Foot Ulcers (DFU): An Open-Label Randomized Controlled Trial

2020 ◽  
Vol 9 (12) ◽  
pp. 4032
Author(s):  
José Luis Lázaro-Martínez ◽  
Francisco Javier Álvaro-Afonso ◽  
David Sevillano-Fernández ◽  
Yolanda García-Álvarez ◽  
Irene Sanz-Corbalan ◽  
...  
Keyword(s):  
Diabetic Foot ◽  
Cellular Proliferation ◽  
Controlled Trial ◽  
Surgical Debridement ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Wound Debridement ◽  
Randomized Controlled ◽  
Ultrasound Assisted ◽  
Surgical Group

We aimed to evaluate the effects of ultrasound-assisted wound (UAW) debridement on cellular proliferation and dermal repair in complicated diabetic foot ulcers as compared to diabetic foot ulcers receiving surgical/sharp wound debridement. A randomized controlled trial was performed involving 51 outpatients with complicated diabetic foot ulcers that either received surgical debridement (n = 24) or UAW debridement (n = 27) every week during a six-week treatment period. Compared to patients receiving surgical debridement, patients treated with UAW debridement exhibited significantly improved cellular proliferation, as determined by CD31 staining, Masson’s trichrome staining, and actin staining. Bacterial loads were significantly reduced in the UAW debridement group compared to the surgical group (UAW group 4.27 ± 0.37 day 0 to 2.11 ± 0.8 versus surgical group 4.66 ± 1.21 day 0 to 4.39 ± 1.24 day 42; p = 0.01). Time to healing was also significantly lower (p = 0.04) in the UAW group (9.7 ± 3.8 weeks) compared to the surgical group (14.8 ± 12.3 weeks), but both groups had similar rates of patients that were healed after six months of follow-up (23 patients (85.1%) in the UAW group vs. 20 patients (83.3%) in the surgical group; p = 0.856). We propose that UAW debridement could be an effective alternative when surgical debridement is not available or is contraindicated for use on patients with complicated diabetic foot ulcers.

scholarly journals The LeucoPatch® system in the management of hard-to-heal diabetic foot ulcers: study protocol for a randomised controlled trial

Trials ◽  
2017 ◽  
Vol 18 (1) ◽  
Author(s):  
Frances Game ◽  
William Jeffcoate ◽  
Lise Tarnow ◽  
Florence Day ◽  
Deborah Fitzsimmons ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Study Protocol ◽  
Diabetic Foot ◽  
Controlled Trial ◽  
Foot Ulcers ◽  
Diabetic Foot Ulcers ◽  
Randomised Controlled
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