Diabetic Foot UlcerOG/SNaPNCT01623882
Clinical Evaluation of the Combined Use of Apligraf® and the SNaP® Pressure Wound Therapy System
An observational study of Diabetic Foot Ulcer, run by KCI USA, Inc.
Trial summary
The primary purpose of this study is to evaluate the safety and efficacy of the concurrent use of Apligraf® and the SNaP® Wound Care System for the treatment of diabetic and venous stasis lower extremity ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Dec 2015
- Phase
- Observational
- 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
Study population: Patients with lower extremity venous and diabetic ulcers.
Who may be able to join
- Wound < 10 cm in greatest diameter
- Wound age > 4 weeks and patient shows < 50% wound area healing after 4 weeks of treatment
- Patient > 18 years of age
- Patient is willing and able to sign consent
- Patient is willing and able to complete study visits and comply with study dressing protocols
Who cannot join
- Wound size reduction of > 50% in last 4 weeks of treatment
- Patients with active wound infections, including cellulitis and osteomyelitis
- Patients with wounds not able to have eschar debrided
- ABI < 0.65 or SPP < 30mmHg
- Patients with wounds in anatomic areas which preclude achieving an airtight seal for NPWT
- Ulcers due to inflammatory conditions such as rheumatoid arthritis, lupus, scleroderma, vasculitis, calciphylaxis, etc.
Show all 11Show fewer
- Patients with allergy to or intolerance of any of the wound dressing materials expected to be used during the trial.
- Pregnant patients
- Patients unable to tolerate NPWT
- Patients with dialysis dependent ESRD
- Index ulcer is on the plantar surface of the foot
About this study
Official title: Clinical Evaluation of the Combined Use of Apligraf® and the SNaP® Negative Pressure Wound Therapy System for Treatment of Non-responding Venous Stasis and Diabetic Lower Extremity Ulcers
The primary purpose of this study is to evaluate the safety and efficacy of the concurrent use of Apligraf® and the SNaP® Wound Care System for the treatment of diabetic and venous stasis lower extremity ulcers.
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetes Mellitus, Wounds, Ulcers
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Wounds and Injuries, Ulcer
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of wounds closed
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2014
- Study completionDec 2015
Why it stopped: The study was terminated by Spiracur (original sponsor). Efforts were made to contact the PI/study team members, but were unsuccessful.
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- KCI USA, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Organogenesis, 3M
- Responsible party
- Sponsor
- Investigators
- Peter Schubart, MD, PhD, Principal investigator, O'Connor Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01623882
- Sponsor's protocol ID
- 041311
- Acronym
- OG/SNaP
- Status last verified
- Nov 2024
- First submitted
- 18 Jun 2012
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Combined Use of Apligraf® and the SNaP® Negative Pressure Wound Therapy System for Treatment of Non-responding Venous Stasis and Diabetic Lower Extremity Ulcers
- ClinicalTrials.gov ID
- NCT01623882
- Acronym / sponsor ID
- OG/SNaP / 041311
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetes Mellitus, Wounds, Ulcers
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study was terminated by Spiracur (original sponsor). Efforts were made to contact the PI/study team members, but were unsuccessful.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- KCI USA, IncIndustry (pharma, biotech, devices)
- Collaborators
- Organogenesis, 3M
- Study start
- Jun 2012 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 20 Jun 2012 (estimated)
- 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 primary purpose of this study is to evaluate the safety and efficacy of the concurrent use of Apligraf® and the SNaP® Wound Care System for the treatment of diabetic and venous stasis lower extremity ulcers.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lower extremity venous and diabetic ulcers.
Key inclusion criteria (5 listed)
- Wound < 10 cm in greatest diameter
- Wound age > 4 weeks and patient shows < 50% wound area healing after 4 weeks of treatment
- Patient > 18 years of age
- Patient is willing and able to sign consent
- Patient is willing and able to complete study visits and comply with study dressing protocols
Key exclusion criteria (11 listed)
- Wound size reduction of > 50% in last 4 weeks of treatment
- Patients with active wound infections, including cellulitis and osteomyelitis
- Patients with wounds not able to have eschar debrided
- ABI < 0.65 or SPP < 30mmHg
- Patients with wounds in anatomic areas which preclude achieving an airtight seal for NPWT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of wounds closed
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
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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.
Peter Schubart, MD, PhD principal investigator
O'Connor Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Foot Ulcer, run by KCI USA, Inc.
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 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: withdrawn, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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 wounds closed (time frame: 12 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 25 Nov 2024.