Diabetic Foot UlcerNCT03640988
The Effects of High Energy Acoustic Shock Wave Therapy on Local Skin Perfusion and DFUs
A study testing dermaPACE in people with Diabetic Foot Ulcer, run by SANUWAVE, Inc. at 1 site in United States.
Trial summary
This is an observational, single-arm, on-label study. This clinical study will be conducted at up to 2 sites with a total of 10 subjects per site. All subjects will receive standard of care treatment which includes DFU treatments with the dermaPACE device. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- dermaPACE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2019to 3 Jan 2021
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is male or female ≥22 years of age at Visit 1;
- Wagnergrade 1 or 2 DFU;
- In the leg with the target ulcer has an ABI > 0.70 and < 1.20 OR if the ABI is >1.20 has a toe pressure >50 mmHg at Visit 1
- Has only one diabetic foot ulcer that is located on the plantar surface of the forefoot that has persisted a minimum of 30 days prior to the first visit.
- Has Type I or Type II Diabetes Mellitus;
- HbA1c < 12% at Visit 1;
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- Patient is willing to comply with all study requirements and treatment visits.
- Patient is willing to comply with off-loading directions.
- Patient is willing to comply with offloading instructions
Who cannot join
- Potential subjects who meet any of the following criteria will be excluded from participating in the study.
- A subject who:
- Is female and is currently pregnant or plans to become pregnant during the study;=, or is a female who is nursing aor actively lactating;
- Known or suspected systemic infection;
- Enrolled in another investigational study;
- Has received growth factor therapy (e.g., autologous platelet-rich plasma, stem cell therapy, becaplermin, cell therapy, dermal substitute, amniotic tissue, extracellular matrix) within 30 days of study enrollment;
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- Subject is currently receiving or has received radiation or chemotherapy within 3 months of study enrollment;
- Unable to tolerate offloading footwear or total contact casting (TCC);
- Has active cellulitis either at the site of, or in the surrounding area of, the target ulcer at Visit 1 or 2;
- Has active Charcot foot at Visit 1 or 2;
- Has osteomyelitis in the foot or ankle on which the target ulcer is located at Visit 1 or 2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Post-market Pilot Study to Evaluate the Effects of High Energy Acoustic Shock Wave Therapy on Local Skin Perfusion and Healing of Diabetic Foot Ulcers
This is an observational, single-arm, on-label study. This clinical study will be conducted at up to 2 sites with a total of 10 subjects per site. All subjects will receive standard of care treatment which includes DFU treatments with the dermaPACE device.
Read the detailed description
The dermaPACE system will be used according to label along with standard of care. perfusion will be measured using TcPO2 methods and also using cleared hyperspectral imaging equipment. The intent of the study is to observe/measure oxygen saturation levels in the area of the treated wound before initiation of dermaPACE treatment, during the treatment period, and two weeks post treatment period
- Conditions
- Diabetic Foot Ulcer
- Being tested
- dermaPACE
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dermaPACEDevice
Shockwave application
| Study group | Role | What they receive |
|---|---|---|
| dermaPACE | Experimental | Non-sterile, single, Benchtop System that is comprised of a dermaPACE Control Console, PACE Applicator and foot pedal. The PACE applicator uses shockwave technology on acute and chronic defects. Receives: Device: dermaPACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin perfusion, effect on oxygenation level, by visit
Measurement of changes in oxygenation levels in superficial tissue before and after treatment with dermaPACE System.
Measured: 10 weeks
Secondary outcomes (2)
Wound healing, effect on wound area, by visit
Measurement of changes in wound area at each visit
Measured: 10 weeks
Wound healing, effect on wound closure, by visit
Measurement of the rate of wound closure at each visit
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start25 Apr 2019
- Primary completion3 Jan 2021
- Study completion3 Jan 2021
Why it stopped: Mfr of product identified in protocol to measure perfusion after treatment with sponsor device withdrew support from the study. Sponsor decided to cancel the investigation due to lack of adequate replacement.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Pulsed acoustic wave on-label application on acute and chronic defects of the skin and subcutaneous soft tissues
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- SANUWAVE, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Granick, MD FACS, Principal investigator, University Hospital/Rutgers University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640988
- Sponsor's protocol ID
- SAN18-DERM02
- Status last verified
- Oct 2021
- First submitted
- 16 Aug 2018
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-market Pilot Study to Evaluate the Effects of High Energy Acoustic Shock Wave Therapy on Local Skin Perfusion and Healing of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT03640988
- Acronym / sponsor ID
- SAN18-DERM02
- Conditions
- Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Mfr of product identified in protocol to measure perfusion after treatment with sponsor device withdrew support from the study. Sponsor decided to cancel the investigation due to lack of adequate replacement.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- SANUWAVE, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- 3 Jan 2021 (actual)
- Study completion
- 3 Jan 2021 (actual)
- First posted
- 21 Aug 2018 (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.
This is an observational, single-arm, on-label study. This clinical study will be conducted at up to 2 sites with a total of 10 subjects per site. All subjects will receive standard of care treatment which includes DFU treatments with the dermaPACE device.
Detailed description
The dermaPACE system will be used according to label along with standard of care. perfusion will be measured using TcPO2 methods and also using cleared hyperspectral imaging equipment. The intent of the study is to observe/measure oxygen saturation levels in the area of the treated wound before initiation of dermaPACE treatment, during the treatment period, and two weeks post treatment period
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pulsed acoustic wave on-label application on acute and chronic defects of the skin and subcutaneous soft tissues
| Arm | Type | Receives |
|---|---|---|
| dermaPACE | Experimental | Device: dermaPACENon-sterile, single, Benchtop System that is comprised of a dermaPACE Control Console, PACE Applicator and foot pedal. The PACE applicator uses shockwave technology on acute and chronic defects. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Is male or female ≥22 years of age at Visit 1;
- Wagnergrade 1 or 2 DFU;
- In the leg with the target ulcer has an ABI > 0.70 and < 1.20 OR if the ABI is >1.20 has a toe pressure >50 mmHg at Visit 1
- Has only one diabetic foot ulcer that is located on the plantar surface of the forefoot that has persisted a minimum of 30 days prior to the first visit.
- Has Type I or Type II Diabetes Mellitus;
Key exclusion criteria (11 listed)
- Potential subjects who meet any of the following criteria will be excluded from participating in the study.
- Is female and is currently pregnant or plans to become pregnant during the study;=, or is a female who is nursing aor actively lactating;
- Known or suspected systemic infection;
- Enrolled in another investigational study;
- Has received growth factor therapy (e.g., autologous platelet-rich plasma, stem cell therapy, becaplermin, cell therapy, dermal substitute, amniotic tissue, extracellular matrix) within 30 days of study enrollment;
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 |
|---|---|---|
| dermaPACEShockwave application | Device | dermaPACE |
Primary outcome
Skin perfusion, effect on oxygenation level, by visit
Time frame: 10 weeks
Measurement of changes in oxygenation levels in superficial tissue before and after treatment with dermaPACE System.
2 secondary outcomes
Wound healing, effect on wound area, by visit
Time frame: 10 weeks
Wound healing, effect on wound closure, by visit
Time frame: 10 weeks
Results and safety
The study was stopped early (reason given: Mfr of product identified in protocol to measure perfusion after treatment with sponsor device withdrew support from the study. Sponsor decided to cancel the investigation due to lack of adequate replacement.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Individual participant dataSharing planned: No
Related trials for Diabetic Foot Ulcer
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Better Care Closer to Home: Enhancing Primary and Community Care
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EDX110 Randomized Control Trial for Treatment of DFUs
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DiaFootCare to Promote Self-Care of Diabetic Foot Ulcers in Oman
Diabetic Foot Ulcer (DFU), Diabetes Mellitus
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.
Mark Granick, MD FACS principal investigator
University Hospital/Rutgers University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dermaPACE in people with Diabetic Foot Ulcer, run by SANUWAVE, Inc. 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 9 inclusion and 11 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 8 Nov 2021. 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.
Are results available for this study?
The study was stopped early (reason given: Mfr of product identified in protocol to measure perfusion after treatment with sponsor device withdrew support from the study. Sponsor decided to cancel the investigation due to lack of adequate replacement.). Results are not available in the source record.
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?
Skin perfusion, effect on oxygenation level, by visit (time frame: 10 weeks). 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 8 Nov 2021; AzTrials last refreshed its copy on 7 Nov 2026.