None listed
Conditions
Brief summary
Chronic, non-healing foot and leg ulcers are often a result of reduced blood flow due to Peripheral Artery Disease (PAD) or other ischemic (reduced blood flow) conditions in patients with chronic diseases, including diabetes. These ulcers can compromise quality of life and increase the risk of serious infection and tissues necrosis (injury and death of the tissue). Periosteal distraction (PD) is a medical technique used to increased blood flow to the affected area of tissue (peripheral perfusion). It works by gently pulling on the thin tissue covering the tibia (periosteum). This tissue plays a key role in encouraging blood flow to the feet and ankles. The XPD system is a new medical device designed to facilitate PD. It consists of both external fixation and implanted components which are surgically fixated to the tibia to apply controlled stress to the periosteum in order to promote blood vessel formation and tissue regeneration. This is a multi-centre, open label, single arm study to evaluate the safety of the XPD System for PD in participants with hard to heal ulcers in the peripheral lower extremities (ankle and below). Chronic ulcers will be graded using the Wound, Ischemia, and foot Infection (WIFi) scale (W)1-2, (I)1-3, (fI)0-1 based on physician judgement. All patients will have a procedure for sharp debridement and installation of the XPD System to perform PD for 3 weeks. The patients will return at 4 weeks for removal of the device and begin an observation period for 16 additional weeks for a total of 20-week follow-up period.
Interventions
The BioDynamik XPD System is intended to be used for increased perfusion of the lower extremities to promote healing of ulcers. The XPD System involves inserting a Distraction Plate under the periosteum surgically, performed by an orthopaedic surgeon. This will take approximately 30 minutes. Following a latency period of three days to allow for healing and tissue adaptation, daily distractions are performed in regular intervals to apply slow and gradual tension on the periosteum. A distraction i
The BioDynamik XPD System is intended to be used for increased perfusion of the lower extremities to promote healing of ulcers. The XPD System involves inserting a Distraction Plate under the periosteum surgically, performed by an orthopaedic surgeon. This will take approximately 30 minutes. Following a latency period of three days to allow for healing and tissue adaptation, daily distractions are performed in regular intervals to apply slow and gradual tension on the periosteum. A distraction involves using a provided hex key, to turn the matching screw in the distraction plate. The periosteal distraction rate is 0.5mm per day, performed in two sessions. Each session involves rotating the actuation screw a half-turn, delivering a precise 0.25mm of movement. The distraction process continues for 20 days until a total of 10mm distraction is achieved. Patients will be performing their own distraction, and are provided with instructional text and a distraction log to ensure compliance. At the end of the distraction phase, a second latency period of two days is observed before returning the device back to the starting position. The retraction procedure is performed by retracting the plate 5mm per day, performed in two 2.5mm retraction sessions per day. Returning the plate to the starting position marks the completion of the periosteal distraction therapy, after which the device is removed surgically from the patient by an orthopaedic surgeon. Following removal of the device, the patient will be observed for an additional 16 weeks to assess safety monitoring, would healing, patient health, and growth factors. The total study duration is 21 weeks (1 week screening, 4 weeks with device inserted, 16-week follow-up).
Sponsors
BioDynamik Inc.
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. Male or female greater than or equal to 18 years 2. Participant is willing and able to sign informed consent 3. Current reference ulcer has been present for greater than 30 days prior to enrolment 4.Using the 'Wound, Ischemia, and Foot Infection' (WIfI) criteria the patient has (W)1-2, (I)1-3, (fI)0-1 5. Patients with a diagnosis of diabetes must have a HbA1c of less than or equal to 12% at screening and considered stable and controlled with no changes in diabetic medication regimen anticipated during the study period 6. Patients with mild/moderate foot ischemia, confirmed at baseline (Day 0) based upon the following criteria for the affected foot: a) Toe Pressure (TP) less than 50 mmHg or b) Ankle Systolic Pressure (ASP) less than or equal to 70 mmHg or c) TcPO2 less than 40 mmHg 7. Participants or responsible caregiver must be willing to undergo protocol-defined standardized wound care and all study procedures during the study period 8. Ulcer is either located on the foot or ankle with at least 50% of ulcer below medial aspect of the malleolus 9. Ulcer size (area) greater than or equal to 1cm2 and less than or equal to 25cm2 at screening visit a) If heel ulcer, area less than 4cm2 10. Females of childbearing potential* must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence) during the course of the study and undergo pregnancy tests (serum or urine) as required
Exclusion criteria
1. Participant was previously enrolled and treated under this clinical study protocol 2. Participant has WIfI (W)3 or (fI)2-3 3. Participant has a history of hypersensitivity to nickel, as determined by prior medical history 4. Participant has participated in another clinical trial involving a device or a systemically administered investigational study drug/treatment within 30 days of enrolment. 5. Participant has a history of bone cancer or metastatic disease on the index limb, radiation therapy to the foot, or has had chemotherapy within twelve (12) months (365 days) prior to signing informed consent form for trial participation 6. Reference ulcer, in the clinical opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer 7. Participants with end-stage renal disease receiving dialysis treatment. 8. In the clinical opinion of the Investigator, the participant has an active or unstable Charcot foot 9. Participant has been treated with wound dressings that include growth factors, engineered tissues or skin substitutes within 30 days of enrolment or is scheduled to receive treatment during the study 10. Participant has been treated with Negative Pressure Wound Therapy (NPWT, hyperbaric oxygen or topical oxygen therapy within thirty (30) days of the Screening Visit or is scheduled to receive such treatments during the study 11. Participant with a history of more than two (2) weeks treatment with immunosuppressants including prednisone 10 mg daily or an equivalent dose of other oral steroids, or application of topical steroids to the ulcer surface within one (1) month (30 days) prior to first Screening Visit, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study. 12. Participant is not considered a good candidate for this clinical trial in the opinion of the investigator.
Outcome results
None listed