DiabetesNCT01011387
Evaluation of Negative Pressure Wound Therapy in the Treatment of DFUs Incl. Post Amputation Wounds.
A study testing NPWT System in people with Diabetes and Foot Ulcers, run by Molnlycke Health Care AB at 2 sites in United Kingdom.
Trial summary
Primary objective To assess wound healing and granulation tissue formation when using the NPWT system Secondary objectives To investigate the pain level at dressing removal To visually check exudate removal To investigate the ease of use for the subject and care giver when using the NPWT system Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Foot Ulcers
- What is being tested?
- NPWT System
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 2010to Jul 2010
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetic foot ulcers (DFUs) including post amputation wounds associated with diabetes suitable for Negative Pressure Wound Therapy according to the investigator's judgment
- 1 cm2 ≤ Wound size ≤ 200 cm2
- Male or female, 18 years and above
- Signed Informed Consent Form
- Subject understands the written subject Information
Who cannot join
- Need for frequent dressing changes, i.e.<72 hours between the changes
- Dry wounds
- Critical ischemia (for wound healing) according to investigator's judgement
- Malignancy in the wound and/or wound margin
- Target ulcer previous not successfully treated with NPWT within 48 hours
- Poorly controlled diabetes according to investigators judgement.
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- Osteomyelitis which has been left untreated
- Infection which has been left untreated
- Unexplored fistula
- > 10% surface area necrotic tissue with eschar present after debridement
- High risk for bleeding complications
- Exposed major blood vessels, organs or nerves
- Current or within 3 months treatment with chemotherapy or irradiation
- Known hypersensitivity to the dressing material
- Expected technically impossible to seal the film to maintain a vacuum for treatment
- Expected non compliance with the Clinical Investigation Plan
- Pregnancy
- Subjects not suitable for the investigation according to the investigator's judgement
- Subjects previously included in this investigation
- Subjects included in other ongoing clinical investigation at present or during the past 30 days
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Freeman Hospital
Newcastle upon Tyne
Norfolk & Norwich University Hospital
Norfolk,
About this study
Official title: A Prospective, Open, Non-controlled Clinical Investigation to Evaluate a NPWT (Negative Pressure Wound Therapy) System to be Used in the Treatment of Diabetic Foot Ulcers (DFUs) Including Post Amputation Wounds Associated With Diabetes.
Primary objective
- To assess wound healing and granulation tissue formation when using the NPWT system
Secondary objectives
- To investigate the pain level at dressing removal
- To visually check exudate removal
- To investigate the ease of use for the subject and care giver when using the NPWT system
Read the detailed description
The investigation is designed as a prospective, open, non-controlled clinical investigation.
Wounds to be treated under this protocol should be Diabetic foot ulcers (DFUs) or post amputation wounds associated with diabetes in hospitalized subjects or subjects treated at home. One ulcer or post amputation wound per subject will be treated for a maximum duration of 4 weeks. All subjects will receive negative pressure treatment with the NPWT system, -120 mm Hg.
In total, 10-15 subjects at two sites will be enrolled provided that they fulfill all the inclusion criteria and none of the exclusion criteria and have signed and dated a written informed consent.
The subjects will be consecutively allocated to a specific subject identification code and the recruitment will be competitive.
The primary variable wound healing and granulation tissue formation will be assessed by digital planimeter, digital photography and visual estimation.
Pain level and subject/investigator convenience will be assessed by convenience surveys.
An evaluable subject is defined as a subject completing the investigation with 4 weeks of treatment, a subject healed before 4 weeks of treatment or if the investigator judge that the wound has adequately responded on NPWT before 4 weeks and that continued treatment can be made with alternative treatment.
- Conditions
- Diabetes, Foot Ulcers
- Being tested
- NPWT System
- Keywords
- Diabetic foot ulcers
- Medical subject headings
- Diabetes Mellitus, Foot Ulcer, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPWT SystemProcedure or surgery
Dressing change 3 times per week
NPWT systemDevice
3 dressing changes/week for maximum 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| NPWT system | Other | Negative pressure wound therapy Receives: Procedure: NPWT System; Device: NPWT system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Wound Area.
Measured by tracing of wound and measured by planimeter.
Measured: From baseline to maximum 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startJan 2010
- Primary completionJul 2010
- Study completionJul 2010
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 DiabetesStudies 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
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Molnlycke Health Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerard Stansby, MD, Prof., Principal investigator, Freeman Hospital, Newcastle upon tyne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011387
- Sponsor's protocol ID
- NPWT 01
- Status last verified
- Mar 2012
- First submitted
- 4 Nov 2009
- Last updated
- 21 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open, Non-controlled Clinical Investigation to Evaluate a NPWT (Negative Pressure Wound Therapy) System to be Used in the Treatment of Diabetic Foot Ulcers (DFUs) Including Post Amputation Wounds Associated With Diabetes.
- ClinicalTrials.gov ID
- NCT01011387
- Acronym / sponsor ID
- NPWT 01
- Conditions
- Diabetes, Foot Ulcers
- Keywords
- Diabetic foot ulcers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Molnlycke Health Care ABIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 11 Nov 2009 (estimated)
- Results
- Posted 21 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective
- To assess wound healing and granulation tissue formation when using the NPWT system
Secondary objectives
- To investigate the pain level at dressing removal
- To visually check exudate removal
- To investigate the ease of use for the subject and care giver when using the NPWT system
Detailed description
The investigation is designed as a prospective, open, non-controlled clinical investigation.
Wounds to be treated under this protocol should be Diabetic foot ulcers (DFUs) or post amputation wounds associated with diabetes in hospitalized subjects or subjects treated at home. One ulcer or post amputation wound per subject will be treated for a maximum duration of 4 weeks. All subjects will receive negative pressure treatment with the NPWT system, -120 mm Hg.
In total, 10-15 subjects at two sites will be enrolled provided that they fulfill all the inclusion criteria and none of the exclusion criteria and have signed and dated a written informed consent.
The subjects will be consecutively allocated to a specific subject identification code and the recruitment will be competitive.
The primary variable wound healing and granulation tissue formation will be assessed by digital planimeter, digital photography and visual estimation.
Pain level and subject/investigator convenience will be assessed by convenience surveys.
An evaluable subject is defined as a subject completing the investigation with 4 weeks of treatment, a subject healed before 4 weeks of treatment or if the investigator judge that the wound has adequately responded on NPWT before 4 weeks and that continued treatment can be made with alternative treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NPWT system | Other | Procedure: NPWT System, Device: NPWT systemNegative pressure wound therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diabetic foot ulcers (DFUs) including post amputation wounds associated with diabetes suitable for Negative Pressure Wound Therapy according to the investigator's judgment
- 1 cm2 ≤ Wound size ≤ 200 cm2
- Male or female, 18 years and above
- Signed Informed Consent Form
- Subject understands the written subject Information
Key exclusion criteria (20 listed)
- Need for frequent dressing changes, i.e.<72 hours between the changes
- Dry wounds
- Critical ischemia (for wound healing) according to investigator's judgement
- Malignancy in the wound and/or wound margin
- Target ulcer previous not successfully treated with NPWT within 48 hours
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 |
|---|---|---|
| NPWT SystemDressing change 3 times per week | Procedure or surgery | NPWT system |
| NPWT system3 dressing changes/week for maximum 4 weeks. | Device | NPWT system |
Primary outcome
Mean Change in Wound Area.
Time frame: From baseline to maximum 4 weeks
Measured by tracing of wound and measured by planimeter.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gerard Stansby, MD, Prof. principal investigator
Freeman Hospital, Newcastle upon tyne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NPWT System in people with Diabetes and Foot Ulcers, run by Molnlycke Health Care AB at 2 sites in United Kingdom.
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 5 inclusion and 20 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 21 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Yes. Results are posted in the registry (first posted 21 Mar 2012). 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?
Mean Change in Wound Area. (time frame: From baseline to maximum 4 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 21 Mar 2012.