Characterization of patients with diabetic foot disease presenting to an Irish Podiatry Centre: profiling suitability for entry to a clinical trial of advanced wound therapeutics

Abstract

This research found an eligibility criterion of wound area 2-10 cm for enrolment in a clinical trial of mesenchymal stromal cell therapy too restrictive. Extension of wound area to 1-10 cm and the inclusion of neuro-ischaemic ulcers increased eligibility for enrolment from 1.4 to 20 %.

Factors Associated with Healing Outcomes in Primary Care Patients with Diabetic Foot Ulcers: A Retrospective Study in a Multiethnic Sample

“…The present study did not find any associations between patient characteristics such as age, ethnicity, body mass index, duration of diabetes, location of diabetes treatment follow-up (hospitals, polyclinics, or general practitioners), or HbA 1c level and 3-month ulcer healing outcomes. This is consistent with several other studies on DFUs 15,27–29 . The present study also found that fewer ischemic ulcers (18.7%) healed within 3 months compared with neuropathic (41.1%) and neuroischemic ulcers (26.7%).…”

“…Univariate analysis showed that ischemic and neuroischemic ulcers were negatively associated with healing within 3 months. Similar results have been reported in other previous studies 27,30,31 …”

“…Similar results have been reported in other previous studies. 27,30,31 Both the univariate and multiple regression analysis in the present study found positive associations between being female and ulcer healing within 3 months. These findings align with the results of a previous study 28 that DFUs in women were twice as likely to heal compared with those in men ( P = .009).…”

“…This is consistent with several other studies on DFUs. 15,[27][28][29] The present study also found that fewer ischemic ulcers (18.7%) healed within 3 months compared with neuropathic (41.1%) and neuroischemic ulcers (26.7%). Univariate analysis showed that ischemic and neuroischemic ulcers were negatively associated with healing within 3 months.…”

“…This finding aligns with several previous studies that found wound size is significantly correlated with wound healing (HR, 1.014; 95% CI, 1.002-1.027; P = .027) 37 and that a larger ulcer size is a predictor for nonhealing or delayed ulcer healing. 8,17,27,38 In the present study, ulcers less than 1 cm 2 had the highest healing proportion (50.9%) compared with ulcers 1 to 10 cm 2 (30.7%) and ulcers greater than 10 cm 2 (25.0%). The univariate analyses revealed that ulcer sizes 1 to 10 cm 2 and greater than 10 cm 2 ( P < .001) were negatively associated with healing within 3 months.…”