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):  
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

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)

scholarly journals The Effect of Bitter Melon (Momordica charantia L.) Leaves Extract on TNF-α Serum Levels and Diabetic Foot Ulcers Improvement : Randomized Controlled Trial

2018 ◽  
Vol 11 (3) ◽  
pp. 1413-1421
Author(s):  
Fahrun Nur Rosyid ◽  
Edi Dharmana ◽  
Ari Suwondo ◽  
K. Heri Nugroho HS ◽  
Sugiarto Sugiarto
Keyword(s):  
Diabetic Foot ◽  
Controlled Trial ◽  
Foot Ulcer ◽  
Diabetic Foot Ulcer ◽  
Foot Ulcers ◽  
Bitter Melon ◽  
Diabetic Foot Ulcers ◽  
Control Groups ◽  
Tnf Α ◽  
And Control

Diabetic foot ulcer (DFU) is among the many complications of diabetes and it takes a very long period of time to heal. It can lead to the amputation of the lower limb, thereby resulting to death or in most cases, a bad quality of life. The aim and objective of this study is to assess the effect of bitter melon leaves extracts on serum TNF-α levels and improvement of diabetic foot ulcers. The study technique used here is the randomized, double-blinded, placebo-controlled trial. Thirty patients suffering from DFU participated in the trial and according to PEDIS scores were divided into two groups, of which 15 patients were in the treatment group and administered with bitter melon leaves extract at a dose of 6 g/day and the remaining 15 patients were in the control group and were given placebo. This intervention was done for 4 weeks and the examination of serum TNF-α levels was carried out at baseline and at the end of treatment. The readings of the healing process for diabetic foot ulcers with PEDIS scores were also taken at baseline, weeks 2, 3 and 4. Data were analyzed using the paired t-test and the independent t test. After 4 weeks of treatment, there was a decrease in baseline serum TNF-α levels in the treatment and control groups (29.5 ± 8.6 pg/ml, P = 0.0001 and 202.5 ± 610.2 pg/ml, P = 0.001). There was no effect on serum TNF-α levels (P = 0.28). There was a decrease in PEDIS degrees from baseline, week 2, 3 and 4 in the treatment and control groups (2.7±0.5; 2.7±0.5; 2.7±0.6; 1.9±0.6 and 2.6±0.5; 2.6±0.5; 2.5±0.6; 2.2±0.8). However there was no effect on diabetic foot ulcer improvement both groups in week 2 (P = 0.46), week 3 (P = 0.57) and week 4 (P = 0.29). Bitter melon leaves extracts is proven to have no effect on the serum TNF-α levels and improvement of diabetic foot ulcers.

scholarly journals Strong association of anemia in people with diabetic foot ulcers (DFUs): Study from a specialist foot care center

2019 ◽  
Vol 35 (5) ◽  
Author(s):  
Abdul Majid Shareef ◽  
Muhammad Yakoob Ahmedani ◽  
Nazish Waris
Keyword(s):  
Diabetic Foot ◽  
Care Center ◽  
Strong Association ◽  
Foot Ulcers ◽  
Control Group ◽  
Case Group ◽  
Diabetic Foot Ulcers ◽  
Foot Care ◽  
And Control ◽  
Age And Sex

Background & Objective: Anemia is common finding in people with diabetes and diabetic foot ulcers. Therefore, our objective was to observe and compare the association of anemia in people with diabetic foot ulcers (DFUs) with age and sex matched people without DFUs. Methods: This prospective case control study was undertaken at a multidisciplinary diabetic foot clinic of Baqai Institute of Diabetology and Endocrinology (BIDE) between October 2014 and October 2015. Participants were categorized into two groups; Case group (people with DFUs) and Control group (people without DFUs). Baseline demographic characteristics, biochemical and hematological parameters were recorded. University of Texas (UT) classification system was used to grade and stage DFU in case group. Subjects with other apparent causes of anaemia were excluded. Age and sex matched controls were taken from diabetic clinic presented during same time period. Data was analyzed by using statistical package for social science (SPSS) version 20. Results: Total of 161 participants in case group were compared with similar number of age and sex matched participants of control group. Most of the participants were males 119(73.9%). Age and sex matched case and control groups were comparable except for duration of diabetes, BMI and HDL levels. Overall, 85.67% case group (males 64.56%); females 21.11%) and 35.3% control group (males 22.9%; females12.4%) have anemia. Mean Hb level was 10.49g/dl in case group and 13.39g/dl in control group. Significant differences were also noted in other blood parameters. Conclusion: Our study concludes that anaemia is strongly associated with DFU disease. Anaemia should be considered and treated as co-morbidity while managing patients with foot ulcers. doi: https://doi.org/10.12669/pjms.35.5.1421 How to cite this:Shareef AM, Ahmedani MY, Waris N. Strong association of anemia in people with diabetic foot ulcers (DFUs): Study from a specialist foot care center. Pak J Med Sci. 2019;35(5):---------. doi: https://doi.org/10.12669/pjms.35.5.1421 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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.

Sign in / Sign up

Export Citation Format

Share Document