Diabetic FootDFUsNCT05506215

Randomized Clinical Study Comparing SynPath to Standard of Care in Treatment of Chronic Diabetic Foot Ulcers

A study testing SynPath Acellular Dermal Matrix plus Off-loading Device and Wound Dressing composed of 90% collagen and 10% Alginate plus Off-loading Device in people with Diabetic Foot and Chronic Foot Ulcer, run by PolyNovo Biomaterials Pty Ltd. at 7 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The study will evaluate the efficacy of SynPath™, a synthetic dermal matrix, in the treatment of diabetic foot ulcers in subjects with diabetes mellitus versus Standard of Care treatment. Half the subjects with be treated using SynPath™ while the other half will receive Standard of Care treatment Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetic Foot, Chronic Foot Ulcer, Wound Healing
What is being tested?: SynPath Acellular Dermal Matrix plus Off-loading Device and Wound Dressing composed of 90% collagen and 10% Alginate plus Off-loading Device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 7 sitesUnited States
Study dates: 10 Jul 2022to 26 Feb 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female ≥ 18 years
A signed and dated informed consent form has been obtained from the subject
Confirmed Type 1 or 2 diabetes with a hemoglobin HbA1c ≤12% within 90 days of informed consent
Current reference ulcer has been in existence for longer than four (4) weeks with confirmed failure of a prior treatment to heal the ulcer, prior to signing informed consent for trial participation. Verbal statement from prior treating clinician or patient can be used as confirmation of treatment failure.
Reference ulcer has been diagnosed as either a partial or full thickness diabetic foot ulcer without tunneling, undermining, sinus tracts or /exposed bone, with a scale rating of a Wagner Grade 1 or Wagner Grade 2 extended to ligament, tendon, and joint capsule with no bone exposure
Ulcer is either located on the foot or ankle with at least 50% of ulcer below medial aspect of the malleolus

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Ulcer size (area) ≥1cm² and ≤25cm² post-debridement at both screening visit 1 and at baseline/randomization visit 3
There is a minimum 1cm margin between the qualifying reference study ulcer and any other ulcers on the specified foot, post debridement
Subject has adequate vascular perfusion of the affected limb, as defined by at least one of the following:
Ankle-brachial Index (ABI) ≥ 0.65 or ≤1.2
Toe pressure (plethysmography) >50mmHg
TcPO2 >40mmHg
Or as an alternative, the arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle or a TBI (Toe Brachial Index) of > 0.6 is acceptable.
Subject or responsible caregiver is willing and able to adhere to schedule of required applicable dressing changes as well as off-loading for the location of the reference ulcer
Subject is able and willing to comply with study procedures
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.
A two-(2) week run-in period will Standard of Care treatment plus required offloading precede randomization in the trial to document the indolent nature of the subject's selected selected. The subject may be randomized if the reference ulcer has not reduced in area >30% from screening visit 1 to baseline/randomization visit 3.

Who cannot join

Subject was previously randomized and treated under this clinical study protocol
Subject has suspected or confirmed signs/symptoms of gangrene or wound infection as evidenced by redness, pain, and purulent drainage on any part of the index limb as confirmed by X-ray or biopsy
Subject has a history of hypersensitivity to polyurethane, as determined by prior medical history
Subject has participated in another clinical trial involving a device or a systemically administered investigational study drug/treatment within 30 days of randomization
Subject has received, or is scheduled to receive a medication or treatment which is known to interfere with or affect the rate or quality of wound healing within 30 days of signing the informed consent form
Subject 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 prior to signing informed consent form for trial participation

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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
Subject has a condition that would interfere with their ability to adhere with the treatment regimen or has a known history of poor adherence with medical treatment
In the opinion of the Investigator, the subject has a history of or is currently diagnosed with any illnesses or conditions, other than diabetes, that could interfere with wound healing such as auto-immune disorders, end-stage renal disease, severe malnutrition, liver disease or connective tissue disorders
In the clinical opinion of the Investigator, the subject has an active or unstable Charcot foot
Subject has ulcers secondary to a disease other than diabetes (e.g., vasculitis, neoplasms, or hematological disorders)
In the clinical opinion of the Investigator, the subject has excessive lymphoedema that could interfere with off-loading and/or wound healing
Subject with an active infection at the reference ulcer
Subject has a non-healed surgical site from a prior amputation located in the index limb that has been open for less than 30 days
Subject has been treated with wound dressings that include growth factors, engineered tissues or skin substitutes within 30 days of randomization or is scheduled to receive treatment during the study
Subject has been treated with hyperbaric oxygen or topical oxygen therapy within five (5) days of the Screening Visit or is scheduled to receive hyperbaric oxygen treatment or topical oxygen therapy during the study
Subject has been treated with Negative Pressure Wound Therapy (NPWT) within 72 hours of the Screening Visit
Subject receiving dialysis treatment: hemodialysis or peritoneal dialysis
Subject has received an organ transplant
Subjects 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 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
Active osteomyelitis or bone infection of the index foot. A subject may be enrolled in study if the subject:
is at least 8 weeks post osteomyelitis diagnosis
has been treated appropriately
has only intact joint capsule exposed with no bone exposure
Subjects presenting with an ulcer probing to bone (Wagner Grade 3)
Subject is currently pregnant or actively trying to conceive.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Center for Clinical Research
Castro Valley, California, 94546
JPS Health Network
Fort Worth, Texas, 76104
Limb Preservation Platform, Inc
Fresno, California, 93710
Foot and Ankle Specialists of Mid-Atlantic, LLC
Salem, Virginia, 24153
Barry University Clinical Research
Tamarac, Florida, 33321
ILD Research Center
Vista, California, 92083
Lower Extremity Institute for Research and Therapy, LLC
Youngstown, Ohio, 44512

Other trials in United States

About this study

Official title: A Prospective, Multicenter, Open Label, Randomized, Controlled Clinical Study Evaluating the Effect of NovoSorb ® SynPath™ Dermal Matrix Compared to Standard of Care (SOC) In the Treatment of Nonresponsive, Chronic Diabetic Foot Ulcers.

The study will evaluate the efficacy of SynPath™, a synthetic dermal matrix, in the treatment of diabetic foot ulcers in subjects with diabetes mellitus versus Standard of Care treatment.

Half the subjects with be treated using SynPath™ while the other half will receive Standard of Care treatment

Read the detailed description

One hundred and thirty-eight (138) subjects with chronic Diabetic Foot Ulcers ranging in size from 1cm2 to 25cm2 will be randomized 1:1 to either SynPath™ or Standard of Care after the completion of a 14 day screening/run-in period. Following the of run-in period the subjects with a 'hard to heal' or chronic, (>4 weeks) nonresponsive Wagner Grade 1 or 2 diabetic foot ulcer will be randomized to receive either SynPath™ or SOC treatment. Both treatment groups will require subjects to use off-loading device.

Conditions: Diabetic Foot, Chronic Foot Ulcer, Wound Healing, Foot Ulcer
Being tested: SynPath Acellular Dermal Matrix plus Off-loading Device, Wound Dressing composed of 90% collagen and 10% Alginate plus Off-loading Device
Keywords: Ulcer, Diabetic, Acellular Dermal Matrix Template, Diabetes Complications
Medical subject headings: Diabetic Foot, Foot Ulcer, Ulcer, Diabetes Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SynPath Acellular Dermal Matrix plus Off-loading DeviceDevice
Application of SynPath
Wound Dressing composed of 90% collagen and 10% Alginate plus Off-loading DeviceDevice
Application Wound Dressing composed of Collagen and Alginate

Study groups in NCT05506215
Study group	Role	What they receive
NovoSorb SynPath	Experimental	Arm receives application on NovoSorb SynPath Dermal Matrix and appropriate Off-loading Receives: Device: SynPath Acellular Dermal Matrix plus Off-loading Device
Standard of Care	Active comparator	Arm receives application of wound dressing composed of 90% Collagen and 10% Alginate plus appropriate Off-loading Receives: Device: Wound Dressing composed of 90% collagen and 10% Alginate plus Off-loading Device

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of ulcer closed at 12 weeks
Complete wound closure was defined as 100% re-epithelialization of the ulcer surface without drainage or dressing requirements confirmed at 2 consecutive study visits 2 weeks apart
Measured: 12 weeks

Secondary outcomes (6)

Percentage of ulcers that achieved 50% or greater closure rate within 6 weeks
The percentage of ulcers that achieve 50% or greater closure
Measured: 6 weeks
Comparison of closure rates for each treatment group
Comparison of rates of wound closure between Standard of Care and SynPath
Measured: 12 weeks
Percent Wound Area Reduction(PWAR) over 12 weeks
The Change in percentage wound reduction(PWVR) over 12 weeks for each treatment group
Measured: 12 Weeks
Cost of treatment in each treatment group
Calculation of cost of treatment including number of device applications for each treatment group
Measured: 12 weeks
Change in reported Pain Levels between each treatment group
Change in subject reported pain levels using the 0-10 Numerical Pain Scale
Measured: 12 weeks
The type and number of serious adverse events experienced
Comparison of the type and number of serious adverse events experience for each treatment group
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jul 202226 Feb 2024

First posted18 Aug 2022
Study start10 Jul 2022
Primary completion26 Feb 2024
Study completion26 Feb 2024

Why it stopped: After review of study data, sponsor determined wound bed preparation prior to product application was not being followed. A new study will be considered with clearer definition of wound bed preparation and strict adherence to the steps for use.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Diabetic FootStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05506215
Sponsor's protocol ID: CP-005
Acronym: DFUs
Status last verified: Feb 2024
First submitted: 16 Aug 2022
Last updated: 5 Mar 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence

All Diabetic Foot trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multicenter, Open Label, Randomized, Controlled Clinical Study Evaluating the Effect of NovoSorb ® SynPath™ Dermal Matrix Compared to Standard of Care (SOC) In the Treatment of Nonresponsive, Chronic Diabetic Foot Ulcers.
ClinicalTrials.gov ID: NCT05506215
Acronym / sponsor ID: DFUs / CP-005
Conditions: Diabetic Foot, Chronic Foot Ulcer, Wound Healing, Foot Ulcer
Keywords: Ulcer, Diabetic, Acellular Dermal Matrix Template, Diabetes Complications
Study type: Interventional
Recruitment status: TerminatedReason stopped: After review of study data, sponsor determined wound bed preparation prior to product application was not being followed. A new study will be considered with clearer definition of wound bed preparation and strict adherence to the steps for use.
Enrolment: 25 participants (actual)
Lead sponsor: PolyNovo Biomaterials Pty Ltd.Industry (pharma, biotech, devices)
Study start: 10 Jul 2022 (actual)
Primary completion: 26 Feb 2024 (actual)
Study completion: 26 Feb 2024 (actual)
First posted: 18 Aug 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study will evaluate the efficacy of SynPath™, a synthetic dermal matrix, in the treatment of diabetic foot ulcers in subjects with diabetes mellitus versus Standard of Care treatment.

Half the subjects with be treated using SynPath™ while the other half will receive Standard of Care treatment

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
NovoSorb SynPath	Experimental	Device: SynPath Acellular Dermal Matrix plus Off-loading DeviceArm receives application on NovoSorb SynPath Dermal Matrix and appropriate Off-loading
Standard of Care	Active comparator	Device: Wound Dressing composed of 90% collagen and 10% Alginate plus Off-loading DeviceArm receives application of wound dressing composed of 90% Collagen and 10% Alginate plus appropriate Off-loading

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

Male or female ≥ 18 years
A signed and dated informed consent form has been obtained from the subject
Confirmed Type 1 or 2 diabetes with a hemoglobin HbA1c ≤12% within 90 days of informed consent
Current reference ulcer has been in existence for longer than four (4) weeks with confirmed failure of a prior treatment to heal the ulcer, prior to signing informed consent for trial participation. Verbal statement from prior treating clinician or patient can be used as confirmation of treatment failure.
Reference ulcer has been diagnosed as either a partial or full thickness diabetic foot ulcer without tunneling, undermining, sinus tracts or /exposed bone, with a scale rating of a Wagner Grade 1 or Wagner Grade 2 extended to ligament, tendon, and joint capsule with no bone exposure

Key exclusion criteria (26 listed)

Subject was previously randomized and treated under this clinical study protocol
Subject has suspected or confirmed signs/symptoms of gangrene or wound infection as evidenced by redness, pain, and purulent drainage on any part of the index limb as confirmed by X-ray or biopsy
Subject has a history of hypersensitivity to polyurethane, as determined by prior medical history
Subject has participated in another clinical trial involving a device or a systemically administered investigational study drug/treatment within 30 days of randomization
Subject has received, or is scheduled to receive a medication or treatment which is known to interfere with or affect the rate or quality of wound healing within 30 days of signing the informed consent form

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SynPath Acellular Dermal Matrix plus Off-loading DeviceApplication of SynPath	Device	NovoSorb SynPath
Wound Dressing composed of 90% collagen and 10% Alginate plus Off-loading DeviceApplication Wound Dressing composed of Collagen and Alginate	Device	Standard of Care

Primary outcome

Percentage of ulcer closed at 12 weeks
Time frame: 12 weeks
Complete wound closure was defined as 100% re-epithelialization of the ulcer surface without drainage or dressing requirements confirmed at 2 consecutive study visits 2 weeks apart

6 secondary outcomes

Percentage of ulcers that achieved 50% or greater closure rate within 6 weeks
Time frame: 6 weeks
Comparison of closure rates for each treatment group
Time frame: 12 weeks
Percent Wound Area Reduction(PWAR) over 12 weeks
Time frame: 12 Weeks
Cost of treatment in each treatment group
Time frame: 12 weeks
Change in reported Pain Levels between each treatment group
Time frame: 12 weeks
The type and number of serious adverse events experienced
Time frame: 12 weeks

Results and safety

The study was stopped early (reason given: After review of study data, sponsor determined wound bed preparation prior to product application was not being followed. A new study will be considered with clearer definition of wound bed preparation and strict adherence to the steps for use.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
Individual participant dataSharing planned: No

Related trials for Diabetic Foot

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Charles M Zelen, DPM, FACFAC study director

Profession Education and Research Institute, LLC

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of ulcer closed at 12 weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05506215.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.