The randomized controlled trial is the most robust method available to evaluate health-care treatments. If podiatric medical practice is to be based on rigorous evidence, then high-quality randomized controlled trials are needed to inform that practice. In this article, we examine the extent to which randomized controlled trials are used in recent podiatric medical research and appraise the quality of those that are available. Using the Cochrane database of all randomized controlled trials in health care, we found only six relevant trials undertaken in podiatric medicine since 1997. These studies were of variable quality. We also discuss the key features of a rigorous trial design. To date, the clinical practice of podiatric medicine is not adequately informed by the best available evidence. We call for more high-quality randomized controlled trials to be undertaken in podiatric medical research. (J Am Podiatr Med Assoc 94(3): 221–228, 2004)
The purposes of this study were to develop an instrument to assess the validity of randomized controlled trials and to report on the differences in the validity of randomized controlled trials between two podiatric medical journals and a mainstream medical journal. The study demonstrated that after adequate training, there can be agreement among reviewers evaluating the quality of published randomized controlled trials using an established instrument and guidelines. The results of the study indicate that randomized controlled trials published in podiatric medical journals are less credible than those published in a mainstream medical journal. (J Am Podiatr Med Assoc 93(5): 392-398, 2003)
Background: Diabetic foot ulcers (DFUs) are main cause of hospitalizations and amputations in diabetic patients. Failure of standard foot care is the most important cause of impaired DFUs healing. Dakin's solution (DS; sodium hypochlorite) is a promising broad spectrum bactericidal antiseptic for DFUs management. Studies investigating the efficacy of using DS solution on DFUs healing process are scarce. Accordingly, this is the first evidence based randomized control trial study conducted to evaluate the effect of using diluted DS compared with the standard care in the management of infected DFUs. Methods: Randomized control trial study was conducted to assess the efficacy of DS in the management of infected DFUs. Patients were randomly distributed to control group (DFUs irrigated with normal saline) and intervention group (DFUs irrigated with 0.1% DS). Patients were followed for at least 24 weeks for healing, reinfection or amputations. In-vitro antimicrobial testing on DS was performed including determination of its minimum inhibitory concentration (MIC), minimum bactericidal concentration (MBC), minimum biofilm inhibitory concentration (MBIC), minimum biofilm eradication concentration (MBEC) and suspension test. Results: Replacing normal saline irrigation in DFU standard care with 0.1% DS followed by soaking the ulcer with commercial sodium hypochlorite (0.08 %) after patient discharge significantly improved ulcer healing (p< 0.001) and decreased number of amputations and hospitalizations (p< 0.001). The endpoint of death from any cause (RR 0.13; p = 0.029) and the amputation rate (RR 0.27; p<0.001) were also significantly reduced. The effect on ulcer closure (OR 11.9; p<0.001) was significantly enhanced in comparison to the control group. Moreover, DS irrigation for inpatients, significantly decreased bacterial load (p< 0.001), The in-vitro analysis results of DS were: MIC (1.44%), MBC (2.88%), MBIC (1.08%) and MBEC (2.87%). Conclusions: Compared with standard care, diluted DS (0.1%) was more effective in the management of infected DFUs. DS (0.1%) irrigation with debridement followed by standard care is a promising method in the management of infected DFUs.
Background: Diabetic foot ulcers (DFUs) are the main cause of hospitalizations and amputations in diabetic patients. Failure of standard foot care is the most important cause of impaired DFU healing. Dakin’s solution (DS) is a promising broad-spectrum bactericidal antiseptic for management of DFUs. Studies investigating the efficacy of using DS on the healing process of DFUs are scarce. Accordingly, this is the first evidence-based, randomized, controlled trial conducted to evaluate the effect of using diluted DS compared with the standard care in the management of infected DFUs.
Methods: A randomized controlled trial was conducted to assess the efficacy of DS in the management of infected DFUs. Patients were distributed randomly to the control group (DFUs irrigated with normal saline) or the intervention group (DFUs irrigated with 0.1% DS). Patients were followed for at least 24 weeks for healing, reinfection, or amputations. In vitro antimicrobial testing on DS was performed, including determination of its minimum inhibitory concentration, minimum bactericidal concentration, minimum biofilm inhibitory concentration, minimum biofilm eradication concentration, and suspension test.
Results: Replacing normal saline irrigation in DFU standard care with 0.1% DS followed by soaking the ulcer with commercial sodium hypochlorite (0.08%) after patient discharge significantly improved ulcer healing (P < .001) and decreased the number of amputations and hospitalizations (P < .001). The endpoint of death from any cause (risk ratio, 0.13; P = .029) and the amputation rate (risk ratio, 0.27; P < .001) were also significantly reduced. The effect on ulcer closure (OR, 11.9; P < .001) was significantly enhanced in comparison with the control group. Moreover, DS irrigation for inpatients significantly decreased bacterial load (P < .001). The highest values for the in-vitro analysis of DS were as follows: minimum inhibitory concentration (MIC), 1.44%; minimum bactericidal concentration (MBC), 1.44%; minimum biofilm inhibitory concentration (MBIC), 2.16%; and minimum biofilm eradication concentration (MBEC), 2.87%.
Conclusions: Compared with standard care, diluted DS (0.1%) was more effective in the management of infected DFUs. Dakin’s solution (0.1%) irrigation with debridement followed by standard care is a promising method in the management of infected DFUs.
Achieving timely healing of foot ulcers can help avoid complications such as infection and amputation; topical oxygen therapy has shown promise in achieving this. We evaluated the clinical effectiveness of Granulox, a hemoglobin spray device designed to deliver oxygen to the surface of wounds, for the healing of foot ulcers.
We conducted a single-center, prospective, randomized controlled trial comparing standard of care (once-weekly podiatric medical clinic visits) versus standard care plus adjunct Granulox therapy twice weekly in adults with foot ulcers. After a 2-week screening phase, patients in whom the index wound had healed by less than 50% were randomized 1:1. Outcome measures were collated during the trial phase at 6 and 12 weeks.
Of 79 patients enrolled, 38 were randomized. After 12 weeks, the median percentage wound size reduction compared with the size of the ulcer at the start of the trial phase was 100% for the control arm and 48% for the Granulox arm (P = .21, Mann-Whitney U test). In the former, eight of 14 foot ulcers had healed; in the latter, four of 15 (P = .14, Fisher exact test). In the control arm, two amputations and one withdrawal occurred, whereas in the Granulox arm, one unrelated death and five withdrawals were recorded.
We could not replicate the favorable healing associated with use of Granulox as published by others. Differences in wound chronicity and frequency of Granulox application might have influenced differences in study results. Granulox might perform best when used as an adjunct for treatment of chronic wounds at least 8 weeks old.
Up to 10% of people will experience heel pain. The purpose of this prospective, double-blind, randomized clinical trial was to compare custom foot orthoses (CFO), prefabricated foot orthoses (PFO), and sham insole treatment for plantar fasciitis.
Seventy-seven patients with plantar fasciitis for less than 1 year were included. Outcome measures included first step and end of day pain, Revised Foot Function Index short form (FFI-R), 36-Item Short Form Health Survey (SF-36), activity monitoring, balance, and gait analysis.
The CFO group had significantly improved total FFI-R scores (77.4 versus 57.2; P = .03) without group differences for FFI-R pain, SF-36, and morning or evening pain. The PFO and CFO groups reported significantly lower morning and evening pain. For activity, the CFO group demonstrated significantly longer episodes of walking over the sham (P = .019) and PFO (P = .03) groups, with a 125% increase for CFOs, 22% PFOs, and 0.2% sham. Postural transition duration (P = .02) and balance (P = .05) improved for the CFO group. There were no gait differences. The CFO group reported significantly less stretching and ice use at 3 months.
The CFO group demonstrated 5.6-fold greater improvements in spontaneous physical activity versus the PFO and sham groups. All three groups improved in morning pain after treatment that included standardized athletic shoes, stretching, and ice. The CFO changes may have been moderated by decreased stretching and ice use after 3 months. These findings suggest that more objective measures, such as spontaneous physical activity improvement, may be more sensitive and specific for detecting improved weightbearing function than traditional clinical outcome measures, such as pain and disease-specific quality of life.
Background: Although there are studies showing that extracorporeal shockwave therapy (ESWT) and instrument-assisted soft-tissue mobilization methods are effective in chronic plantar heel pain (CPHP) treatment, there is a need for studies comparing these techniques. We compared the effectiveness of ESWT versus instrument-assisted soft-tissue mobilization using Graston Technique (GT) instruments in addition to stretching exercises (SEs) in CPHP.
Methods: Sixty-nine patients were randomly assigned to three groups: ESWT+SEs (group 1), GT+SEs (group 2), and SEs only (control group) (ratio, 1:1:1). The SEs, twice daily for 8 weeks, were standard for all. Group 1 received low-intensity ESWT; in group 2, GT was the selected method. Visual analog scales (for initial step and activity pain), the Foot Function Index (FFI), the 12-item Short-Form Health Survey (SF-12), and the Tampa Scale for Kinesiophobia were used pretreatment, posttreatment, and at 8-week and 6-month follow-up.
Results: Visual analog scale and FFI scores improved posttreatment and during follow-up in all groups (P < .001). Although effect sizes were greater in groups 1 and 2 than in the control group in initial step pain posttreatment and at 8-week follow-up, group 2 had the highest effect size at 6 months. Mean SF-12 scores in groups 1 and 2 improved on the posttreatment assessment. Furthermore, group 2 showed significant improvements in FFI scores compared with the other groups at 6-month follow-up (F = 6.33; P = .003).
Conclusions: Although ESWT+SEs and GT+SEs seem to have similar effects on initial step pain posttreatment and at 8-week follow-up, GT+SEs was found most effective for improving functional status at 6 months in the management of CPHP.