Monitoring wound status using multi-parameter optical fibre sensors

Not Applicable

• Conditions: Diabetic foot ulcer; Skin and Connective Tissue Diseases

• Registration Number: ISRCTN43662626
• Lead Sponsor: niversity of Nottingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-30
• Last Update Posted: 25 March 2024
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 10

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified