Health impacts of seated arm ergometry training in patients with a diabetic foot ulcer: protocol for a randomised controlled trial

IntroductionOnce diagnosed with a diabetic foot ulcer (DFU), patients are advised to offload, keeping pressure off the foot in order to facilitate ulcer healing. An increase in offloading is often accompanied by reductions in physical activity which can worsen the overall health of patients.While unable to perform traditional forms of upright activity, one mode of exercise that would allow patients to be physically active while adhering to offloading instruction is seated arm ergometry. The merits of tailored aerobic exercise in DFU remain unexplored.Methods and analysisThis is a prospective open-label randomised controlled trial. Participants will be randomised to one of two groups, an exercise intervention group or control. The intervention group are required to undertake arm ergometry training at a moderate intensity (65%–75% HRpeak), three times per week for 12 weeks as individually prescribed by an exercise physiologist, while the control group will continue to receive standard care alone. Assessment of outcome measures will occur at baseline and after the intervention period, these will include: a seated VO2 peak test, a blood sample, a short physical performance battery, a dual-energy X-ray absorptiometry scan and completing a range of health-based questionnaires. The above will be used to determine: cardiorespiratory fitness, metabolic health, physical function, body composition and quality of life, respectively. Ulcer area will also be measured as an approximate marker of ulcer healing.Ethics and disseminationThis trial has been approved by ‘Yorkshire & The Humber—Leeds West Research Ethics Committee’ (19/YH/0269). Trial results will be published in peer-reviewed journals and through conference presentations.Trial registration numberISRCTN16000053. Registered in accordance with WHO Trial Registration Data Set (version 1.3.1).

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An intervention to optimise coach-created motivational climates and reduce athlete willingness to dope (CoachMADE): a three-country cluster randomised controlled trial

British Journal of Sports Medicine ◽

10.1136/bjsports-2019-101963 ◽

2020 ◽

pp. bjsports-2019-101963

Author(s):

Nikos Ntoumanis ◽

Eleanor Quested ◽

Laurie Patterson ◽

Stella Kaffe ◽

Susan H Backhouse ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Intervention Group ◽

Cluster Randomised Controlled Trial ◽

Trial Registration ◽

Perceived Effectiveness ◽

Cluster Randomised ◽

Randomised Controlled

ObjectivesCoach-centred antidoping education is scarce. We tested the efficacy of a motivationally informed antidoping intervention for coaches, with their athletes’ willingness to dope as the primary outcome.MethodsWe delivered a cluster randomised controlled trial in Australia, the UK and Greece. This study was a parallel group, two-condition, superiority trial. Participants were 130 coaches and 919 athletes. Coaches in the intervention group attended two workshops and received supplementary information to support them in adopting a motivationally supportive communication style when discussing doping-related issues with their athletes. Coaches in the control condition attended a standard antidoping workshop that provided up-to-date information on antidoping issues yet excluded any motivation-related content. Assessments of willingness to dope (primary outcome) and other secondary outcomes were taken at baseline, postintervention (3 months) and at a 2-month follow up.ResultsCompared with athletes in the control group, athletes in the intervention group reported greater reductions in willingness to take prohibited substances (effect size g=0.17) and psychological need frustration (g=0.23) at postintervention, and greater increases in antidoping knowledge (g=0.27) at follow-up. Coaches in the intervention group reported at postintervention greater increases in efficacy to create an antidoping culture (g=0.40) and in perceived effectiveness of need supporting behaviours (g=0.45) to deal with doping-related situations. They also reported greater decreases in doping attitudes (g=0.24) and perceived effectiveness of need thwarting behaviours (g=0.35).ConclusionsAntidoping education programmes should consider incorporating principles of motivation, as these could be beneficial to coaches and their athletes. We offer suggestions to strengthen these programmes, as most of the effects we observed were not sustained at follow-up.Trial registration numberThis trial has been registered with the Australian New Zealand Clinical Trials Registry (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371465&isReview=true).

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Multiple Interventions for Diabetic Foot Ulcer Treatment Trial (MIDFUT): study protocol for a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2019-035947 ◽

2020 ◽

Vol 10 (4) ◽

pp. e035947

Author(s):

Sarah Brown ◽

Jane Nixon ◽

Myka Ransom ◽

Rachael Gilberts ◽

Nikki Dewhirst ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Phase Ii ◽

Treatment Strategy ◽

Controlled Trial ◽

Foot Ulcer ◽

Diabetic Foot Ulcer ◽

Primary Objective ◽

Phase Iii ◽

Randomised Controlled ◽

Post Randomisation

IntroductionDiabetes affects more than 425 million people worldwide with a lifetime risk of diabetic foot ulcer (DFU) of up to 25%. Management includes wound debridement, wound dressings, offloading, treatment of infection and ischaemia, optimising glycaemic control; use of advanced adjuvant therapies is limited by high cost and lack of robust evidence.Methods and analysisA multicentre, seamless phase II/III, open, parallel group, multi-arm multi-stage randomised controlled trial in patients with a hard-to-heal DFU, with blinded outcome assessment. A maximum of 447 participants will be randomised (245 participants in phase II and 202 participants in phase III). The phase II primary objective will determine the efficacy of treatment strategies including hydrosurgical debridement ± decellularised dermal allograft, or the combination with negative pressure wound therapy, as an adjunct to treatment as usual (TAU), compared with TAU alone, with patients randomised in a 1:1:1:2 allocation. The outcome is achieving at least 50% reduction in index ulcer area at 4 weeks post randomisation.The phase III primary objective will determine whether one treatment strategy, continued from phase II, reduces time to healing of the index ulcer compared with TAU alone, with participants randomised in a 1:1 allocation. Secondary objectives will compare healing status of the index ulcer, infection rate, reulceration, quality of life, cost-effectiveness and incidence of adverse events over 52 weeks post randomisation. Phase II and phase III primary endpoint analysis will be conducted using a mixed-effects logistic regression model and Cox proportional hazards regression, respectively. A within-trial economic evaluation will be undertaken; the primary economic analysis will be a cost-utility analysis presenting ICERs for each treatment strategy in rank order of effectiveness, with effects expressed as quality-adjusted life years.The trial has predefined progression criteria for the selection of one treatment strategy into phase III based on efficacy, safety and costs at 4 weeks.Ethics and disseminationEthics approval has been granted by the National Research Ethics Service (NRES) Committee Yorkshire and The Humber - Bradford Leeds Research Ethics Committee; approved 26 April 2017; (REC reference: 17/YH/0055). There is planned publication of a monograph in National Institute for Health Research journals and main trial results and associated papers in high-impact peer-reviewed journals.Trial registration numberISRCTN64926597; registered on 6 June 2017

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Efficacy of Aloe vera/ Plantago Major Gel in Diabetic Foot Ulcer: A Randomized Double-Blind Clinical Trial

Current Drug Discovery Technologies ◽

10.2174/1570163815666180115093007 ◽

2019 ◽

Vol 16 (2) ◽

pp. 223-231 ◽

Cited By ~ 2

Author(s):

Younes Najafian ◽

Zahra M. Khorasani ◽

Mona N. Najafi ◽

Shokouh S. Hamedi ◽

Marjan Mahjour ◽

...

Keyword(s):

Clinical Trial ◽

Diabetic Foot ◽

Intervention Group ◽

Aloe Vera ◽

Foot Ulcer ◽

Diabetic Foot Ulcer ◽

Control Group ◽

Plantago Major ◽

Double Blind ◽

Significant Difference

Background:Diabetic foot ulcer (DFU) is one of the most common complications of diabetic patients. Mostly, non-healing DFU leads to infection, gangrene, amputation and even death. High costs and poor healing of the wounds need a new treatment such as alternative medicine. So, the aim of this study was to evaluate the efficacy of Aloe vera/ Plantago major gel (Plantavera gel) in healing of DFUMethods:Forty patients with DFU enrolled in a double-blind randomized clinical trial. The patients who were randomly assigned into the intervention group (n = 20), received topical Plantavera gel in addition to the routine cares, whereas the patients in the control group (n = 20), received topical Placebo gel in addition to the routine cares. Intervention was done twice a day for 4 weeks in the both groups. Photography and an evaluation of DFU healing were conducted by a checklist and then were scored at baseline and at the end of each week. The collected data was analyzed by SPSS software.Results:At the end of the study, there was a significant difference between the two groups in terms of total ulcer score (P<0.001) and Plantavera gel significantly reduced the ulcer surface comparing with the control group (P=0.039). However, there was not a significant difference between the two groups (P=0.263) in terms of the ulcer depth. During this study, no side effect was observed for Plantavera gel in the intervention group.Conclusion:Topical Plantavera gel seems to be an effective, cheap and safe treatment. Of course, further studies are required to confirm the properties of the wound healing of this gel.

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Clinical efficacy of a silver-releasing foam dressing in venous leg ulcer healing: a randomised controlled trial

International Wound Journal ◽

10.1111/iwj.12022 ◽

2013 ◽

Vol 11 (6) ◽

pp. 649-655 ◽

Cited By ~ 11

Author(s):

Patricia Senet ◽

Renzo Bause ◽

Bo Jørgensen ◽

Karsten Fogh

Keyword(s):

Randomised Controlled Trial ◽

Clinical Efficacy ◽

Ulcer Healing ◽

Controlled Trial ◽

Leg Ulcer ◽

Venous Leg Ulcer ◽

Randomised Controlled

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Efficacy of a Multi-Component m-Health Diet, Physical Activity, and Sleep Intervention on Dietary Intake in Adults with Overweight and Obesity: A Randomised Controlled Trial

Nutrients ◽

10.3390/nu13072468 ◽

2021 ◽

Vol 13 (7) ◽

pp. 2468

Author(s):

Sasha Fenton ◽

Tracy L. Burrows ◽

Clare E. Collins ◽

Anna T. Rayward ◽

Beatrice Murawski ◽

...

Keyword(s):

Physical Activity ◽

Weight Loss ◽

Randomised Controlled Trial ◽

Dietary Intake ◽

Controlled Trial ◽

Intervention Group ◽

Weight Loss Intervention ◽

Traditional Group ◽

Traditional Diet ◽

Randomised Controlled

This three-arm randomised controlled trial evaluated whether (1) a multi-component weight loss intervention targeting diet, physical activity (PA), and sleep was effective at improving dietary intake over six months and 12 months, compared with a control, and (2) the enhanced diet, PA, and sleep intervention was more effective at improving dietary intake than the traditional diet and PA intervention. A total of 116 adults (70% female, 44.5 years, BMI 31.7 kg/m2) were randomised to either traditional diet and PA intervention; enhanced diet, PA, and sleep intervention; or wait-list control. To examine between-group differences, intervention groups were pooled and compared with the control. Then, the two intervention groups were compared. At six months, the pooled intervention group consumed 1011 fewer kilojoules/day (95% CI −1922, −101), less sodium (−313.2 mg/day; 95% CI −591.3, −35.0), and higher %EI from fruit (+2.1%EI; 95% CI 0.1, 4.1) than the controls. There were no differences in intake between the enhanced and traditional groups at six months. At 12 months, the pooled intervention and control groups reported no significant differences. However, compared to the traditional group, the enhanced reported higher %EI from nutrient-dense foods (+7.4%EI; 95% CI 1.3, 13.5) and protein (+2.4%EI; 95% CI 0.1, 4.6), and reduced %EI from fried/takeaway foods (−3.6%EI; 95% CI −6.5, −0.7), baked sweet products (−2.0%EI; 95% CI −3.6, −0.4), and packaged snacks (−1.1%EI; 95% CI −2.2, −0.3). This weight loss intervention reduced total energy and sodium intakes as well as increased fruit intake in adults at six months. The enhanced intervention group reported improved dietary intake relative to the traditional group at 12 months.

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Intermittent cycles of remote ischemic preconditioning augment diabetic foot ulcer healing

Wound Repair and Regeneration ◽

10.1111/wrr.12269 ◽

2015 ◽

Vol 23 (2) ◽

pp. 191-196 ◽

Cited By ~ 14

Author(s):

Gad Shaked ◽

David Czeiger ◽

Anwar Abu Arar ◽

Tiberiu Katz ◽

Ilana Harman-Boehm ◽

...

Keyword(s):

Ischemic Preconditioning ◽

Ulcer Healing ◽

Diabetic Foot ◽

Foot Ulcer ◽

Diabetic Foot Ulcer ◽

Remote Ischemic Preconditioning

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Health literacy and diabetic foot ulcer healing

Wound Repair and Regeneration ◽

10.1111/wrr.12311 ◽

2015 ◽

Vol 23 (3) ◽

pp. 299-301 ◽

Cited By ~ 16

Author(s):

David J. Margolis ◽

Michelle Hampton ◽

Ole Hoffstad ◽

D. Scot Malay ◽

Stephen Thom

Keyword(s):

Health Literacy ◽

Ulcer Healing ◽

Diabetic Foot ◽

Foot Ulcer ◽

Diabetic Foot Ulcer

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Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomised controlled trial

Yearbook of Medicine ◽

10.1016/s0084-3873(08)70069-5 ◽

2007 ◽

Vol 2007 ◽

pp. 106-107

Author(s):

D.R. Snydman

Keyword(s):

Randomised Controlled Trial ◽

Negative Pressure ◽

Diabetic Foot ◽

Negative Pressure Wound Therapy ◽

Controlled Trial ◽

Wound Therapy ◽

Randomised Controlled

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A Pilot Randomized, Controlled Study of Nanocrystalline Silver, Manuka Honey, and Conventional Dressing in Healing Diabetic Foot Ulcer

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2017/5294890 ◽

2017 ◽

Vol 2017 ◽

pp. 1-15 ◽

Cited By ~ 13

Author(s):

Ka-Kit Tsang ◽

Enid Wai-Yung Kwong ◽

Tony Shing-Shun To ◽

Joanne Wai-Yee Chung ◽

Thomas Kwok-Shing Wong

Keyword(s):

Ulcer Healing ◽

Diabetic Foot ◽

Reduction Rate ◽

Foot Ulcer ◽

Diabetic Foot Ulcer ◽

Size Reduction ◽

Controlled Study ◽

Manuka Honey ◽

Ulcer Size ◽

Randomized Controlled

Nanocrystalline silver (nAg) and Manuka honey (MH) dressing have increasing popularity for treating diabetic foot ulcer (DFU). This study was an open-label randomized controlled trial with three parallel groups’ design in examining the preliminary effectiveness of nAg against MH and conventional dressing in healing DFU in terms of ulcer healing, ulcer infection, and inflammation. 31 participants (11 in the nAg group, 10 in the MH group, and 10 in the convention group) diagnosed with type 2 diabetes were enrolled. Wound cleaning, debridement, and topical dressing application were performed according to the group allocation in each visit at weeks 1, 2, 3, 4, 6, 8, 10, and 12. The results found that the proportions of complete ulcer healing were 81.8%, 50%, and 40% in the nAg, MH, and conventional groups, respectively. The ulcer size reduction rate was potentially higher in the nAg group (97.45%) than the MH group (86.21%) and the conventional group (75.17%). In bacteriology, nAg showed a greater rate of microorganism reduction although it was not significant. To conclude, nAg alginate was potentially superior to MH and conventional dressing in healing diabetic foot ulcer in terms of ulcer size reduction rate.

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