Diabetic foot ulcer Skin and Connective Tissue Diseases
Conditions
Interventions
Participants will be seen at their usual clinical setting within the UHDB diabetic foot clinic. Participants will first receive all usual best patient care including local debridement and a temporary
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with diabetes (according to WHO criteria) aged 18 years or over 2. At least one full-thickness ulcer below the malleolus of either foot, present for 4 weeks or more 3. Ulcer located on the sole or dorsum of the foot 4. No presence of wound necrosis, significant oedema or poor tissue viability that in the opinion of the investigator may be at risk of deterioration with the use of OFSSWM optical probe 5. At least one palpable pulse on the foot of the index limb or an Association of the British Pharmaceutical Industry (ABPI) >0.9 6. Minimum ulcer diameter of 3 mm and maximum of 35 mm 7. Able to attend clinic for four separate visits 8. Estimated glomerular filtration rate (eGFR) >20 and not receiving dialysis
Exclusion criteria
Exclusion criteria: 1. Planned revascularisation during the course of the study or within the 4 weeks preceding the start of the study 2. An ulcer of aetiology other than diabetes 3. Depth of ulcer to bone, suspected or confirmed osteomyelitis 4. Severe infection of the index ulcer in accordance with Infectious Diseases Society of America (IDSA) criteria 5. Active Charcot of the foot of the index ulcer 6. The need for negative pressure wound therapy 7. Unwilling or unable to give written informed consent 8. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, may influence the result of the trial or the participant’s ability to participate in the trial 9. Wound located on the toes or between the toes 10. Wounds in a severe condition e.g. necrotic tissue and/or bleeding wounds
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Number of participants screened/consented and reasons for not participating, measured using participant consent forms at the start of each patient visit 2. Feasibility of taking measurements for each optical probe parameter (temperature, relative humidity, ammonia, and carbon dioxide) from a wound, measured using internal algorithms for data analysis and comparison with commercial measurement devices after each patient visit. The data collected will only be used to ascertain device performance and it will not be used to alter the normal care pathway of the patient. 3. Patient feedback about the use of the optical probe, collected using a survey at the end of patient participation in the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Wound size measured as per normal clinical care with a Silhouette wound assessment camera (Entec Health Ltd) at the start of each patient visit 2. Incidence of secondary infection measured using baseline assessments as per the clinical protocol, e.g. assessment of ulcer infection by IDSA criteria (0 = none, 1 = mild [limited to skin and subcutaneous tissues and with inflammation limited to within 2cm of wound margin], 2 = moderate [deeper and/or with more extensive inflammation] and 3 = severe [with systemic symptoms and signs]) at the start of each patient visit 3. Pain in the area of the ulcer assessed by patient-completed 100 mm Visual Analogue Scale (VAS) at the start of each patient visit | — |
Countries
England, United Kingdom
Contacts
Public ContactFrances Game
Outcome results
None listed