Diabetic Foot UlcerPhase 2NCT02783066
Novel Offloading for Diabetic Foot Ulcers With PulseFlow: A Prospective Study
A Phase 2 study testing Offloading boot: PulseFlow in people with Diabetic Foot Ulcer and Offloading, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Diabetic foot ulceration (DFU) is a common and largely preventable complication of diabetes. While most of these ulcers can be treated successfully, some will persist and become infected. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot Ulcer, Offloading
- What is being tested?
- Offloading boot: PulseFlow
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 30 Oct 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18- 80 years old
- type II diabetes with active plantar ulcer,
Who cannot join
- Non-ambulatory or unable to stand without help or walk a distance of at least 6 feet without assistance
- Plantar ulcer on arch of the foot
- Patients with PAD (Ankle Brachial Index < 0.5)
- Acute foot fracture
- Heart failure
- Pregnant women
Show all 10Show fewer
- Patients on immunosuppressive drugs
- Participation in an interventional study in the last 30 days
- Major amputation
- Patients unable or unwilling to participate in all procedures and follow-up evaluations.
Trial locations and contacts
1 site in 1 country.
About this study
Diabetic foot ulceration (DFU) is a common and largely preventable complication of diabetes. While most of these ulcers can be treated successfully, some will persist and become infected. Ultimately, nearly one fifth of patients with infected lower-extremity diabetic ulcers will require amputation of the affected limb, resulting in staggering costs for both the patient and the healthcare system. Prevention by identifying people at higher risk is key for better clinical management of such patients. It is not uncommon for patients suffering from diabetes to have concomitant lower extremity edema or venous insufficiency and they subsequently may benefit from graduated compression. However, because of the common association of peripheral arterial disease (PAD) in patients with diabetes, most clinicians are reluctant to apply compressive dressings in fear of exacerbating the symptoms of PAD and possibility of gangrene.
A novel low voltage, battery powered medical device, PulseFlow DF® (The Diabetic Boot Company, Ltd. UK) has endeavored to assist in the treatment of Diabetic Foot Ulcers. The device provides hybrid functionality i.e. mobile air bladder pump at plantar arch and offloading boot. The air bladder inflates to 160 mmHg for approx. 1 second then deflates back to atmospheric pressure, allowing the plantar vessels sufficient time to refill. The offloading boot design holds the foot and lower leg in a position that reduces shear and friction forces and provides a reduction in plantar pressure.
Read more
The PulseFlow DF is designed to record how many hours of blood pumping it has delivered. This data will be downloaded at each clinic visit. The boot cannot pump blood around the participant's foot unless fitted correctly and the battery is charged up overnight.
The purpose of this study is to conduct an interventional study study with N=15 diabetic subjects with active foot ulcers to assess whether PulseFlow foot compression device can help improve lower extremity perfusion, whilst improving balance and spatio-temporal parameters of gait.
The key goals of the proposed project are to test whether a specially designed compression device can improve lower extremity perfusion, whilst also simultaneously improving the balance and walking performance. Investigators envision the use of this specially designed offloading device with compression capability will help reduce the incidence of diabetic foot ulcers in high-risk diabetic patients. In addition, investigators assumed the proposed device might enhance daily physical activity as well as walking performance. Investigators will conduct a prospective clinical study to validate these hypotheses. Potential changes in walking and spontaneous daily physical activities will be assessed using validated technologies that include walking analyzer system, balance assessment using body worn sensors, and computerized pressure insoles.
- Conditions
- Diabetic Foot Ulcer, Offloading
- Being tested
- Offloading boot: PulseFlow
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Offloading boot: PulseFlowDevice
A new offloading boot, which may enhance balance, gait, and lower extremity blood flow
| Study group | Role | What they receive |
|---|---|---|
| "PulseFlow" group | Experimental | Eligible subjects will try a new offloading boot for 4 weeks Receives: Device: Offloading boot: PulseFlow |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower Extremity Perfusion Change From Baseline to 4 Weeks
Skin perfusion measured in the ankle using Sensilase device. To measure Skin Perfusion Pressure (SPP), a pressure cuff is first automatically inflated to occlude arterial bed blood flow; this is verified by PAD-IQ by determining when perfusion has stopped. The pressure is then automatically released at a controlled rate while the cuff pressure and skin perfusion are measured. A graph displays pressure and perfusion during cuff deflation and indicates the pressure at which skin perfusion is found to return.
Measured: baseline and 4 weeks
Gait Speed Difference Between Pulseflow Offflaoding and Standard Offloading
the quality of walking while wearing Pulseflow offflaoding compared to standard offloading
Measured: baseline
Secondary outcomes (9)
Adherence
adherence to wear offloading boot by downloading from the study device to a specific developed software. The measure is the mean number of minutes the offloading boot was worn for over the course of 4 weeks
Measured: 4 weeks
Wound Size Change From Baseline to 4 Weeks.
measuring the size of the wound (W, L,H)
Measured: baselineand and 4 weeks
Stride Length Difference Between Pulseflow Offflaoding and Standard Offloading
the quality of walking while wearing Pulseflow offflaoding compared to standard offloading
Measured: baseline
Limp Difference Between Pulseflow Offflaoding and Standard Offloading
Limp: the difference in stance percent between right and left feet
Measured: baseline
Peak Swing Angular Velocity
Angular Velocity of leg swing during walking for each side
Measured: baseline
Ratio of Propulsion Time to Stance Time
Propulsion time and stance time for each stride is caulcated by wearable sensors. The measure is ratio of propulsion time to stance time as percentage value.
Measured: baseline
Center of Mass Sway While Wearing Standard Offloading Boot
Center of Mass (COM) sway measured by wearable inertial sensors
Measured: baseline
Center of Mass Sway While Wearing Pulseflow Offloading
center of mass sway measured by a wearable inertial sensor
Measured: baseline
Peak Forefoot Pressure
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study startJan 2016
- Primary completion30 Jun 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Diabetic Boot Company
- Responsible party
- Principal investigator, Bijan Najafi, PhD, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783066
- Sponsor's protocol ID
- H-37713
- Status last verified
- Jul 2020
- First submitted
- 19 May 2016
- Last updated
- 12 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Only de-identified data and associated results will be published in peer-reviewed papers or scientific abstracts
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Offloading for Diabetic Foot Ulcers With PulseFlow: A Prospective Study
- ClinicalTrials.gov ID
- NCT02783066
- Acronym / sponsor ID
- H-37713
- Conditions
- Diabetic Foot Ulcer, Offloading
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- The Diabetic Boot Company
- Study start
- Jan 2016
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 26 May 2016 (estimated)
- Results
- Posted 12 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetic foot ulceration (DFU) is a common and largely preventable complication of diabetes. While most of these ulcers can be treated successfully, some will persist and become infected. Ultimately, nearly one fifth of patients with infected lower-extremity diabetic ulcers will require amputation of the affected limb, resulting in staggering costs for both the patient and the healthcare system. Prevention by identifying people at higher risk is key for better clinical management of such patients. It is not uncommon for patients suffering from diabetes to have concomitant lower extremity edema or venous insufficiency and they subsequently may benefit from graduated compression. However, because of the common association of peripheral arterial disease (PAD) in patients with diabetes, most clinicians are reluctant to apply compressive dressings in fear of exacerbating the symptoms of PAD and possibility of gangrene.
A novel low voltage, battery powered medical device, PulseFlow DF® (The Diabetic Boot Company, Ltd. UK) has endeavored to assist in the treatment of Diabetic Foot Ulcers. The device provides hybrid functionality i.e. mobile air bladder pump at plantar arch and offloading boot. The air bladder inflates to 160 mmHg for approx. 1 second then deflates back to atmospheric pressure, allowing the plantar vessels sufficient time to refill. The offloading boot design holds the foot and lower leg in a position that reduces shear and friction forces and provides a reduction in plantar pressure.
The PulseFlow DF is designed to record how many hours of blood pumping it has delivered. This data will be downloaded at each clinic visit. The boot cannot pump blood around the participant's foot unless fitted correctly and the battery is charged up overnight.
The purpose of this study is to conduct an interventional study study with N=15 diabetic subjects with active foot ulcers to assess whether PulseFlow foot compression device can help improve lower extremity perfusion, whilst improving balance and spatio-temporal parameters of gait.
The key goals of the proposed project are to test whether a specially designed compression device can improve lower extremity perfusion, whilst also simultaneously improving the balance and walking performance. Investigators envision the use of this specially designed offloading device with compression capability will help reduce the incidence of diabetic foot ulcers in high-risk diabetic patients. In addition, investigators assumed the proposed device might enhance daily physical activity as well as walking performance. Investigators will conduct a prospective clinical study to validate these hypotheses. Potential changes in walking and spontaneous daily physical activities will be assessed using validated technologies that include walking analyzer system, balance assessment using body worn sensors, and computerized pressure insoles.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| "PulseFlow" group | Experimental | Device: Offloading boot: PulseFlowEligible subjects will try a new offloading boot for 4 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18- 80 years old
- type II diabetes with active plantar ulcer,
Key exclusion criteria (10 listed)
- Non-ambulatory or unable to stand without help or walk a distance of at least 6 feet without assistance
- Plantar ulcer on arch of the foot
- Patients with PAD (Ankle Brachial Index < 0.5)
- Acute foot fracture
- Heart failure
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 |
|---|---|---|
| Offloading boot: PulseFlowA new offloading boot, which may enhance balance, gait, and lower extremity blood flow | Device | "PulseFlow" group |
Primary outcome
Lower Extremity Perfusion Change From Baseline to 4 Weeks
Time frame: baseline and 4 weeks
Skin perfusion measured in the ankle using Sensilase device. To measure Skin Perfusion Pressure (SPP), a pressure cuff is first automatically inflated to occlude arterial bed blood flow; this is verified by PAD-IQ by determining when perfusion has stopped. The pressure is then automatically released at a controlled rate while the cuff pressure and skin perfusion are measured. A graph displays pressure and perfusion during cuff deflation and indicates the pressure at which skin perfusion is found to return.
Gait Speed Difference Between Pulseflow Offflaoding and Standard Offloading
Time frame: baseline
the quality of walking while wearing Pulseflow offflaoding compared to standard offloading
9 secondary outcomes
Adherence
Time frame: 4 weeks
Wound Size Change From Baseline to 4 Weeks.
Time frame: baselineand and 4 weeks
Stride Length Difference Between Pulseflow Offflaoding and Standard Offloading
Time frame: baseline
Limp Difference Between Pulseflow Offflaoding and Standard Offloading
Time frame: baseline
Peak Swing Angular Velocity
Time frame: baseline
Ratio of Propulsion Time to Stance Time
Time frame: baseline
Center of Mass Sway While Wearing Standard Offloading Boot
Time frame: baseline
Center of Mass Sway While Wearing Pulseflow Offloading
Time frame: baseline
Peak Forefoot Pressure
Time frame: baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Only de-identified data and associated results will be published in peer-reviewed papers or scientific abstracts
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Offloading boot: PulseFlow in people with Diabetic Foot Ulcer and Offloading, run by Baylor College of Medicine at 1 site in United States.
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 2 inclusion and 10 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: finished, as of the sponsor's last update on 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Lower Extremity Perfusion Change From Baseline to 4 Weeks (time frame: baseline and 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2020.