Diabetic Foot UlcerPhase 3NCT01181453
Pivotal Trial of Dermagraft(R) to Treat Diabetic Foot Ulcers
A Phase 3 study testing Dermagraft and Comparator in people with Diabetic Foot Ulcer, run by Organogenesis at 1 site in United States.
Trial summary
This study randomly assigns patients with diabetic foot ulcers to receive standard therapy (surgical debridement, saline-moistened gauze and offloading) alone or standard therapy plus Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an absorbable Vicryl mesh. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Dermagraft and Comparator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 1998to Mar 2000
- Phase
- Phase 3
- 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
- Patient is 18 years of age or older.
- Patient has type I or II diabetes.
- Foot ulcer has been present for a minimum of 2 weeks under the current investigator's care.
- Foot ulcer is on the plantar surface of the forefoot or heel.
- Ulcer size is >/=1.0 cm2 at Day 0 (day of randomization).
- Ulcer extends through the dermis and into subcutaneous tissue but without exposure of muscle, tendon, bone, or joint capsule.
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- Ulcer is free of necrotic debris, exhibits no signs of clinical infection, and appears to be made up of healthy vascularized tissue.
- Patient's Ankle-Arm Index by Doppler is >/=0.7.
- Patient has adequate circulation to the foot as evidenced by a palpable pulse.
- Female patients of child bearing potential must not be pregnant and must use accepted means of birth control.
- Patient and caregiver are willing to participate in the clinical study and can comply with the follow-up regimen.
- Patient or his/her legal representative has read and signed the Institutional Review Board (IRB) approved Informed Consent form before treatment.
- Patient's study ulcer has been present (open) for at least 6 weeks at the time of the Screening visit.
Who cannot join
- There is clinical evidence of gangrene on any part of the affected foot.
- The study ulcer is over a Charcot deformity.
- The study ulcer is due to a nondiabetic etiology.
- The ulcer has tunnels or sinus tracts that cannot be completely debrided.
- The ulcer is >20 cm2 (longest dimension cannot be greater than 5 cm).
- The ulcer has increased or decreased in size by 50% or more during the screening period.
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- Presence of medical condition(s) that in the Investigator's opinion makes the patient an inappropriate candidate for this study.
- Presence of a malignant disease not in remission for 5 years or more.
- Evidence of severe malnutrition, based on a serum albumin level <2.0.
- Presence of patient having known alcohol or drug abuse.
- A random blood sugar reading >/=450 mg/dL.
- Presence of urine ketones that are noted to be "Small, Moderate, or Large".
- Presence of a nonstudy ulcer on the study foot within 7.0 cm of the study ulcer at Day 0.
- Use of oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents, Coumadin or heparin during the study.
- A history of bleeding disorder.
- Presence of Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV).
- Participation in another study involving treatment with an investigational product within the previous 30 days.
- Elective osseous procedures to the study foot within 30 days prior to the Screening visit.
- Previous treatment with Dermagraft®.
- Presence in study ulcer of cellulitis, osteomyelitis or other clinical evidence of infection.
- Presence of condition(s) that seriously compromise the patient's ability to complete this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina School of Medicine
Chapel Hill, North Carolina, 27514
About this study
Official title: A Prospective, Multicenter, Randomized, Single-Blind, Phase III, Clinical Investigation of Dermagraft(R) in Patients With Plantar Diabetic Foot Ulcers
This study randomly assigns patients with diabetic foot ulcers to receive standard therapy (surgical debridement, saline-moistened gauze and offloading) alone or standard therapy plus Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an absorbable Vicryl mesh. Patients are seen weekly until they heal or the 12-week treatment period is complete.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Dermagraft, Comparator
- Keywords
- Diabetic foot ulcer, Randomized trial, Clinical trial, Dermagraft, Standard care
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermagraftDevice
Also called human fibroblast derived dermal substitute
Weekly application of Dermagraft(R) with standard care
ComparatorOther
Also called standard of care, off-loading, surgical debridement, wet-to-moist dressing
Weekly application of standard care
| Study group | Role | What they receive |
|---|---|---|
| Dermagraft(R) | Experimental | Weekly application of Dermagraft(R) with standard care Receives: Device: Dermagraft |
| Standard care only | Other | Weekly application of standard care Receives: Other: Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete wound closure
Measured: 12 weeks
Secondary outcomes (2)
Time to reach complete wound closure
Measured: 12 weeks
Percent of wound closure by study end
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 posted13 Aug 2010 (estimated)
- Study startDec 1998
- Primary completionMar 2000
- Study completionMar 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organogenesis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William A Marston, MD, Principal investigator, University of North Carolina School of Medicine, Chapel Hill, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181453
- Sponsor's protocol ID
- ABH-DG-04-07-0798
- Status last verified
- May 2018
- First submitted
- 12 Aug 2010
- Last updated
- 21 May 2018
- Results posted
- No
Publications
Marston WA, Hanft J, Norwood P, Pollak R; Dermagraft Diabetic Foot Ulcer Study Group. The efficacy and safety of Dermagraft in improving the healing of chronic diabetic foot ulcers: results of a prospective randomized trial. Diabetes Care. 2003 Jun;26(6):1701-5. doi: 10.2337/diacare.26.6.1701.
PubMed 12766097
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Single-Blind, Phase III, Clinical Investigation of Dermagraft(R) in Patients With Plantar Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT01181453
- Acronym / sponsor ID
- ABH-DG-04-07-0798
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetic foot ulcer, Randomized trial, Clinical trial, Dermagraft, Standard care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 314 participants (actual)
- Lead sponsor
- OrganogenesisIndustry (pharma, biotech, devices)
- Study start
- Dec 1998
- Primary completion
- Mar 2000 (actual)
- Study completion
- Mar 2000 (actual)
- First posted
- 13 Aug 2010 (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.
This study randomly assigns patients with diabetic foot ulcers to receive standard therapy (surgical debridement, saline-moistened gauze and offloading) alone or standard therapy plus Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an absorbable Vicryl mesh. Patients are seen weekly until they heal or the 12-week treatment period is complete.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dermagraft(R) | Experimental | Device: DermagraftWeekly application of Dermagraft(R) with standard care |
| Standard care only | Other | Other: ComparatorWeekly application of standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patient is 18 years of age or older.
- Patient has type I or II diabetes.
- Foot ulcer has been present for a minimum of 2 weeks under the current investigator's care.
- Foot ulcer is on the plantar surface of the forefoot or heel.
- Ulcer size is >/=1.0 cm2 at Day 0 (day of randomization).
Key exclusion criteria (21 listed)
- There is clinical evidence of gangrene on any part of the affected foot.
- The study ulcer is over a Charcot deformity.
- The study ulcer is due to a nondiabetic etiology.
- The ulcer has tunnels or sinus tracts that cannot be completely debrided.
- The ulcer is >20 cm2 (longest dimension cannot be greater than 5 cm).
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 |
|---|---|---|
| DermagraftAlso: human fibroblast derived dermal substituteWeekly application of Dermagraft(R) with standard care | Device | Dermagraft(R) |
| ComparatorAlso: standard of care, off-loading, surgical debridement, wet-to-moist dressingWeekly application of standard care | Other | Standard care only |
Primary outcome
Complete wound closure
Time frame: 12 weeks
2 secondary outcomes
Time to reach complete wound closure
Time frame: 12 weeks
Percent of wound closure by study end
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2018.
- Results publication: PubMed 12766097Marston WA, Hanft J, Norwood P, Pollak R; Dermagraft Diabetic Foot Ulcer Study Group. The efficacy and safety of Dermagraft in improving the healing of chronic diabetic foot ulcers: results of a prospective randomized trial. Diabetes Care. 2003 Jun;26(6):1701-5. doi: 10.2337/diacare.26.6.1701.
Related trials for Diabetic Foot Ulcer
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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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.
William A Marston, MD principal investigator
University of North Carolina School of Medicine, Chapel Hill, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dermagraft and Comparator in people with Diabetic Foot Ulcer, run by Organogenesis 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 13 inclusion and 21 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 May 2018. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complete wound closure (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 NCT01181453, which also lists 1 linked publication.
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 May 2018.