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.
Clinicians often use foot orthoses to manage the symptoms of plantar fasciitis. Although there has been considerable research evaluating the effectiveness of orthoses for this condition, there is still a lack of scientific evidence that is of suitable quality to fully inform clinical practice. Randomized controlled trials are recognized as the “gold standard” when evaluating the effectiveness of treatments. We discuss why randomized controlled trials are so important, the features of a well-conducted randomized controlled trial, and some of the problems that arise when trial design is not sound. We then evaluate the available evidence for the use of foot orthoses, with particular focus on published randomized controlled trials. From the evidence to date, it seems that foot orthoses do have a role in the management of plantar fasciitis and that prefabricated orthoses are a worthwhile initial management strategy. At this time, however, it is not possible to recommend either prefabricated or customized orthoses as being better, and it cannot be inferred that customized orthoses are more effective over time and therefore have a cost advantage. Additional good-quality randomized controlled trials are needed to answer these questions. (J Am Podiatr Med Assoc 94(6): 542–549, 2004)
Placebo cure rates vary among randomized clinical trials for onychomycosis, but the factors influencing these cure rates have not been systematically investigated. The PubMed database and reference sections of relevant publications were searched for randomized controlled trials of dermatophyte toenail onychomycosis that included a placebo control and that assessed cure rates. From 21 studies, the pooled mean ± SD placebo cure rates regarding mycological, clinical, and complete cure were 8.7% ± 3.7%, 3.4% ± 2.2%, and 1.2% ± 1.4%, respectively. There was no statistically significant difference between oral and topical treatments. None of the cure rates significantly correlated with any of the participant or study design characteristics analyzed. Placebo cure rates in randomized controlled trials of toenail onychomycosis are relatively low and are independent of the study characteristics.