None listed
Conditions
Brief summary
Complex diabetic foot wounds such as those with exposed tendon, muscle, fascia, joint or bone, present a great therapeutic challenge to health care professionals. This research aims to assess the use of a biodegradable temporising matrix (BTM) in reconstruction of complex diabetic foot wounds. BTM is entirely synthetic matrix made of polyurethane and works as a scaffold that results in creation of new dermis-like layer. It has the potential to improve wound healing complex wounds as it has been demonstrated in previous human studies. Participants will be diabetic patients with deep complex foot. Intervention will consist of of application of BTM in theatre followed by split skin grafting at a later date if necessary. Wound healing will be assessed using a WoundVue camera, which is a hand held portable device that takes 2D and 3D images and provides wound measurements.
Interventions
Application of biodegradable temporising matrix (BTM) to complex diabetic foot wounds (defined by exposure of deep structures such as tendon, bone and joint). This may be followed by skin grafting approximately 4 weeks later.
It is a single application in theatre which will be performed by a Plastic Surgeon. Following this intervention the wound will needed to be dressed 2 times a week for approximately 4 weeks. Dressing changes will be performed by a nurse specialist in wound under supervis
Application of biodegradable temporising matrix (BTM) to complex diabetic foot wounds (defined by exposure of deep structures such as tendon, bone and joint). This may be followed by skin grafting approximately 4 weeks later. It is a single application in theatre which will be performed by a Plastic Surgeon. Following this intervention the wound will needed to be dressed 2 times a week for approximately 4 weeks. Dressing changes will be performed by a nurse specialist in wound under supervision of plastic surgeon. Wounds larger than 4sq cm will be considered for skin grafting approximately 4 weeks post BTM application. Skin grafting will be performed in theatre by a plastic or vascular surgeon with experience in this procedure.
Sponsors
Dr Joseph Dawson
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age greater than 18 years 2. Diagnosis of diabetes, as determined by HbA1c greater than 6.5% or currently on diabetic medication 3. HBA1c less than 12% taken prior to enrolment 4. Foot wound larger than 1cm2 5. Complex deep wounds with exposed tendon, muscle, fascia, joint or bone, for which direct skin grafting may not be recommended. 6. Acceptable circulation to the affected extremity, as demonstrated by one of the following within the past 60 days: a) Transcutaneous oxygen pressure (TcPO2) around the wound greater than 25mmHg, b) Toe pressure greater than 30mmHg, c) Doppler arterial waveforms biphasic or triphasic in at least one artery at the ankle level 7. Have read and agreed to participate voluntarily and signed an informed consent form
Exclusion criteria
1. Active infection – as defined by presence of at least 2 of the following items: local swelling or induration / erythema > 0.5cm around the wound / local tenderness or pain / local warmth / purulent discharge 2. Patients currently receiving radiation therapy or chemotherapy 3. Patient with uncontrolled autoimmune connective disease 4. Evidence of osteomyelitis on imaging tests (x-ray; bone scan; MRI) 5. Patients who are pregnant of breast feeding 6. Patients unable to be followed-up in the Adelaide metropolitan area
Outcome results
None listed