Does close glycaemic control promote healing in diabetic foot ulcers? Report of a feasibility study

Abstract

It was concluded that although evidence is required to guide future practice in this field, the study design chosen was not feasible.

Barriers and enablers to patient recruitment for randomised controlled trials on treatment of chronic wounds: A systematic review

“…Operational factors that prevented authors from achieving their target sample size were reported in 11 studies (40.7%), including a lack of funding ( n = 5), time constraints ( n = 4), and having to compete with other trials concurrently recruiting patients ( n = 3). First, the small amount of funding resources meant that minimal incentives could be provided to the recruitment site, which would be unattractive as “commercially funded trials often offer reimbursement to the host institution at a 10‐20‐fold greater level” than what researchers could offer .…”

“…Of all the included studies, 5 reported to have extended the recruitment period, but only 1 study attained the target sample size, and the rest did not . Third, concurrent trials impacted the number of eligible patients that could be approached . Idris and colleagues found that, of those who were seen at the recruitment site, “29% were debarred by involvement in other studies” …”

“…Third, concurrent trials impacted the number of eligible patients that could be approached . Idris and colleagues found that, of those who were seen at the recruitment site, “29% were debarred by involvement in other studies” …”

“…Patient‐related factors, such as study burden, treatment preference, and logistic difficulty, were reported in 9 studies (33.3%) . The study burden outlined by the authors was either related to intervention, such as an intensive intervention involving vigilant self‐monitoring and a 12‐week home‐based exercise regimen, or to outcome measurement requiring extensive testing or requiring extra visits . In 3 studies, it was reported that, even if eligible, patients had a preference for a product that they regarded as effective for their wound and were, therefore, unwilling to participate in an RCT knowing that they could be receiving their disfavoured product .…”

“…Five studies (18.5%) had difficulty obtaining agreement from the clinicians to assist with recruitment . Considering the workload of clinicians, it was difficult for clinicians to invest their time and resources to take part in research activities .…”