A comparison of wound healing in diabetic foot wounds using a Biodegradable Temporising Matrix (BTM) scaffold technology versus usual standard of care.

Not Applicable

Recruiting

• Conditions: Diabetic neuroischemic wound; Diabetic foot ulcer; Diabetes; Tissue ischemia; Surgery - Surgical techniques; Metabolic and Endocrine - Diabetes; Skin - Other skin conditions

• Registration Number: ACTRN12621001613897
• Lead Sponsor: Flinders Medical Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-26
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete wound healing (100% epithelialisation). This will be determined by visual inspection of the wound by a member of the clinical team (clinicians registered as part of the trial)[ Day 2 post surgery, day 7 post surgery, day 14 post surgery, day 28 post surgery and every 28 day thereafter until wound is healed or 12 months (primary time point).]