ACTRN12621001613897Recruiting未知
Overcoming barriers to wound healing in a neuroischemic diabetic foot cohort using novel tissue augmentation technology (NovoSorb® Biodegradable Temporising Matrix): a randomised control trial.
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Flinders Medical Centre
- Enrollment
- 64
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
Inclusion Criteria
- •Subjects must fulfill all the following inclusion criteria to be eligible to participate in the study:
- •i)Any patient scheduled to undergo:
- •(1)minor amputation of the lower limb (defined as amputation of any anatomical structure distal of the proximal metatarsals).
- •(2)incision and drainage of infected tissue of the foot.
- •(3)surgical revision of existing wound on the lower limb.
- •(4)surgical revision of previous amputation site.
- •(5)any surgery of the lower limb resulting in significant tissue deficit not able to be closed by primary intention
- •ii)Who has an established or new diagnosis of diabetes as determined by HbA1C >6.5% (48mmol/mol) or as represented by pre-existing prescription of diabetes medication (e.g., insulin or oral hypoglycaemics)
- •iii)Whose wounds are scored a moderate (stage 3) or high (stage 4) risk of lower limb amputation based on their presenting wound condition, extent of infection and most recent perfusion assessment (toe pressures or transcutaneous oximetry) using the Society for Vascular Surgery Wound Ischemia and foot Infection (WIfI) classification system.
- •iv)Provides written informed consent prior to any clinical study procedures being performed.
- •v)Willing to comply with all study procedures and expects to be available for the duration of the study
Exclusion Criteria
- •Subjects will not be included if any one or more of the following conditions exist:
- •i.Patients who live interstate, rural or remote or who are not able to attend the scheduled appointed review time frames.
- •ii.Patients under 18 years of age.
- •iii.Patients who are unable to give informed consent due to language difficulties or physical/mental incapacity.
- •iv.Patients planned for a minor amputation or surgical procedure of the lower limb where the operative wound bed will/has been closed using primary closure methods (suture, staples).
- •v.Patients with known hypersensitivity to any polyurethane components of NovoSorb™ BTM.
- •vi.Patients who are pregnant or nursing an infant.
Investigators
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