Monitoring diabetic foot ulcer status using the Optical Fibre Sensing System for Wound Monitoring (OFSSWM)

niversity of Nottingham0 个研究点目标入组 10 人开始时间: 2023年5月30日最近更新: 2024年3月25日

适应症

试验速览

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•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

•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

发起方

niversity of Nottingham