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Trial registered on ANZCTR


Registration number
ACTRN12625000159459p
Ethics application status
Submitted, not yet approved
Date submitted
13/12/2024
Date registered
11/02/2025
Date last updated
11/02/2025
Date data sharing statement initially provided
11/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
First In Human Feasibility Clinical Study Evaluating the Safety of the XPD System for Periosteal Distraction
Scientific title
Evaluating the Safety of the XPD System for Periosteal Distraction in patients with non-healing diabetic foot ulcers
Secondary ID [1] 313567 0
BD-PD-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Foot Ulcers 336078 0
Condition category
Condition code
Skin 332632 332632 0 0
Other skin conditions
Metabolic and Endocrine 332633 332633 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 330159 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340140 0
The primary safety endpoint for this study is a composite outcome of the incidence and severity of adverse events (AEs).
Timepoint [1] 340140 0
Occurence of adverse events will be reviewed weekly post-treatment using the XPD system, for the first 12 weeks. Then at weeks 16 and 20 post-treatment using the XPD system.
Primary outcome [2] 340141 0
Percentage of change in area of ulcers
Timepoint [2] 340141 0
12, 16 and 20 weeks post-treatment using the XPD system compared to baseline measurements.
Secondary outcome [1] 442954 0
Percentage of patients with complete wound healing
Timepoint [1] 442954 0
12, 16 and 20 weeks post-treatment using the XPD system
Secondary outcome [2] 442955 0
Peripheral limb perfusion
Timepoint [2] 442955 0
4 weeks, 6 weeks, 8 weeks, 14 weeks, 16 weeks and 20 weeks post-treatment using the XPD system
Secondary outcome [3] 442956 0
Time to greater than or equal to 50% area reduction wound closure
Timepoint [3] 442956 0
Assessed at 8-weeks, 12-weeks, 16-weeks, and 20-weeks post-treatment using the XPD system.
Secondary outcome [4] 442957 0
Changes in systemic serum level growth factors (vascular endothelial growth factor (VEGF), basic fibroblast growth factor (bFGF), epidermal growth factor (EGF) and platelet-derived growth factor (PDGF)). This will be assessed as a composite outcome.
Timepoint [4] 442957 0
Week 4, week 6, week 8 and week 14 post-treatment using the XPD system
Secondary outcome [5] 442958 0
Peripheral neuropathy
Timepoint [5] 442958 0
Week 8, week 14 and week 16, and 20 post-treatment using the XPD system
Secondary outcome [6] 442959 0
Change in ulcer reported pain
Timepoint [6] 442959 0
Week 4, week 6, week 8 and week 14, week 16, and week 20, post-treatment using the XPD system
Secondary outcome [7] 442960 0
Number of patients with amputation resulting from index wound
Timepoint [7] 442960 0
Investigators will confirm amputation status weekly post-treatment using the XPD system, for the first 12 weeks. Then at weeks 16 and 20 post-treatment using the XPD system.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The general analytical approach for all endpoints will be descriptive in nature. Descriptive statistics for continuous variables will include the number of observations available (n), mean, standard deviation, medians, and interquartile ranges (IQR) as needed, and minimum value, and maximum value. Descriptive statistics for categorical variables will include frequency counts and percentages per category. All missing values will generally not be imputed. All significance tests will be conducted at the level of 0.05 (two-sided) without further multiplicity adjustment in this early-stage feasibility study.

No formal sample size calculation has been performed, and the sample size is empirical. As this is a FIH feasibility study, a sample size of 20 participants is considered sufficient to adequately characterise the general safety profile and preliminary efficacy evidence of XPD System.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2025
Actual
Date of last participant enrolment
Anticipated
1/12/2025
Actual
Date of last data collection
Anticipated
30/04/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,WA

Funding & Sponsors
Funding source category [1] 318030 0
Commercial sector/Industry
Name [1] 318030 0
BioDynamik Inc.
Country [1] 318030 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
BioDynamik Inc.
Address
Country
United States of America
Secondary sponsor category [1] 320376 0
None
Name [1] 320376 0
Address [1] 320376 0
Country [1] 320376 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316687 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 316687 0
Ethics committee country [1] 316687 0
Australia
Date submitted for ethics approval [1] 316687 0
17/12/2024
Approval date [1] 316687 0
Ethics approval number [1] 316687 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138670 0
Dr Olofemi Oshin
Address 138670 0
Royal Perth Hospital. 197 Wellington Street, Perth WA 6000
Country 138670 0
Australia
Phone 138670 0
+61 08 9386 9588
Fax 138670 0
Email 138670 0
olufemi.oshin@health.wa.gov.au
Contact person for public queries
Name 138671 0
Johnny Chen
Address 138671 0
BioDynamik Inc. 11 Orchard Rd Suite 107, Lake Forest, CA 92630
Country 138671 0
United States of America
Phone 138671 0
+1 949 235 5554
Fax 138671 0
Email 138671 0
jchen@biodynamik.com
Contact person for scientific queries
Name 138672 0
Johnny Chen
Address 138672 0
BioDynamik Inc. 11 Orchard Rd Suite 107, Lake Forest, CA 92630
Country 138672 0
United States of America
Phone 138672 0
+1 949 235 5554
Fax 138672 0
Email 138672 0
jchen@biodynamik.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.