Spray on skin for diabetic foot ulcers: an open label randomised controlled trial

Not Applicable

• Conditions: Diabetic Foot Ulcers; Metabolic and Endocrine - Diabetes; Infection - Other infectious diseases; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system; Skin - Other skin conditions

• Registration Number: ACTRN12618000511235
• Lead Sponsor: Department of Health Western Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-09
• Last Update Posted: 16 March 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

i)Age greater than 18years
ii)Diabetes (type 1 or 2) defined according to international consensus guidelines
iii)Admission to FSH or visit to outpatients department at FSH with a DFU requiring local debridement or minor amputation
iv)Ulcer area greater than or equal to 6cm2
v)The ulcer location, contour, shape and wound base is deemed to be suitable for administration of spray on skin
vi)No further debridement or amputation is anticipated
vii)Wound bed is adequately vascularised as determined by the presence of at least one palpable pulse in the affected foot, or at least single vessel run off visualised by arterial Doppler ultrasonography, MRI, CT or conventional angiography (including following revascularisation procedures)
viii)Competent and willing to provide informed consent
ix) Able to be followed up by Silver Chain for community nursing

Exclusion Criteria

i)Non-diabetic neuropathic ulcer
ii) Wounds deemed unsuitable on the basis of contour, location, vascularity or other factors
iii)Limb threatening ischaemia or sepsis requiring early major amputation
iv)Not competent to provide informed consent
v)Unlikely to be accessible for follow-up visit over the next 12 months
vi)Unable to be followed up by Silver Chain ambulatory care nurses

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome for the trial will be a dichotomous outcome of complete healing of the index ulcer at 6 months from enrolment as defined by full epithelialisation, after debridement of callus, lasting for at least 2 weeks. Primary outcome arbitration will be performed using the database, wound dimension and clinical images by two independent senior clinicians blinded (not investigators) to the intervention. Discordant outcome assessments will be resolved by consensus. [The primary outcome is assessed for each individual at 6 months following the date of the enrolment. The planned interim analysis does not refer to the assessment of any individual, rather when the primary outcome is available for the first 80 participants. ]