Diabetic Foot UlcerPhase 3NCT01181440
Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers
A Phase 3 study testing Dermagraft(R) and Conventional care in people with Diabetic Foot Ulcer, run by Organogenesis at 1 site in United States.
Trial summary
This study randomly assigns patients with plantar diabetic foot ulcers to receive conventional therapy (debridement, infection control, saline-moistened gauze dressings, and standardized off-weighting) alone or conventional therapy plus Dermagraft(R). 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(R) and Conventional care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 281 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1994to Jan 1997
- 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 old or older.
- Patient has a current diagnosis of NIDDM or IDDM.
- Patient's ulcer is present for a minimum of two weeks under the current Investigator's care
- The study ulcer has healed <50% in size during the two weeks leading up to randomization
- The study ulcer is on the plantar surface of the forefoot
- The ulcer is >/= 1.0 cm2 at Day 0 (the day of randomization).
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- The ulcer extends through the dermis and into subcutaneous tissue but without exposure of muscle, tendon, bone, or joint capsule.
- The ulcer is free of necrotic debris and clinical infection and is comprised of healthy, vascular tissue and is suitable for skin grafting.
- The patient's Ankle-Arn Index by Doppler is >0.1
- There is adequate circulation to the foot to allow for healing.
- The patient's diabetes is under control as determined by the Investigator.
- Female patients capable of bearing children must test negative for pregnancy and must use an acceptable 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.
Who cannot join
- Patient has clinical evidence of gangrene on any part of the affected foot.
- The ulcer is over a Charcot deformity.
- The ulcer has a nondiabetic etiology.
- The ulcer has tunnels or sinus tracts that cannot be completely debrided.
- The patient's diabetes is uncontrolled and could interfere with the completion of the study.
- There is a medical condition(s) that in the Investigator's opinion make the patient an inappropriate candidate for this study.
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- Patient has/had a malignant disease not in remission for 5 years or more.
- Patient has acute or chronic hepatitis, cirrhosis, has a serum albumin of <2.0 gms/dL, or has alkaline phosphatase or LDH at twice the upper limit of the normal range.
- Patient is receiving oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents, or is anticipated to require such agents during the course of the study.
- Patient has Acquired Immunodeficiency Syndrome (AIDS) or is infected with Human Immunodeficiency Virus (HIV).
- Patient has participated in another study utilizing an investigational drug or device within the previous 30 days.
- The ulcer has cellulitis, osteomyelitis, or other clinical evidence of infection.
- Patient has any condition(s) which seriously compromises their ability to complete this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multicenter, Randomized, Single-Blind Clinical Investigation of Dermagraft(R) in Patients With Plantar Diabetic Foot Ulcers
This study randomly assigns patients with plantar diabetic foot ulcers to receive conventional therapy (debridement, infection control, saline-moistened gauze dressings, and standardized off-weighting) alone or conventional therapy plus Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an absorbable polyglactin (Vicryl) mesh. Patients are evaluated weekly until Week 12, then every four weeks until Week 32.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Dermagraft(R), Conventional care
- Keywords
- Diabetic foot ulcer, Randomized trial, Clinical trial, Dermagraft, Conventional 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.
Dermagraft(R)Device
Also called human fibroblast derived dermal substitute
Weekly application of Dermagraft(R) with conventional care
Conventional careOther
Also called standard of care, off-loading, surgical debridement, wet-to-moist dressing
Weekly application of conventional care
| Study group | Role | What they receive |
|---|---|---|
| Dermagraft(R) and conventional care | Experimental | Not described Receives: Device: Dermagraft(R) |
| Conventional care only | Other | Not described Receives: Other: Conventional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with complete wound closure
Measured: 12 weeks
Secondary outcomes (5)
Proportion of patients with complete wound closure
Measured: 32 weeks
Time to reach 25%,50%,75%, and 100% of wound closure
Measured: 32 weeks
Percent of wound healed
Measured: 12 and 32 weeks
Wound characterization
Measured: 32 weeks
Recurrence of the ulcer
Measured: 32 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 startSep 1994
- Primary completionJan 1997
- Study completionJan 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organogenesis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard A Pollak, DPM, Principal investigator, San Antonio Podiatry Associates, San Antonio, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01181440
- Sponsor's protocol ID
- ABH-DG-04-04-0694
- Status last verified
- May 2018
- First submitted
- 12 Aug 2010
- Last updated
- 21 May 2018
- Results posted
- No
Publications
Naughton G, Mansbridge J, Gentzkow G. A metabolically active human dermal replacement for the treatment of diabetic foot ulcers. Artif Organs. 1997 Nov;21(11):1203-10. doi: 10.1111/j.1525-1594.1997.tb00476.x.
PubMed 9384327Gentzkow GD, Jensen JL, Pollak RA, Kroeker RO, Lerner JM, Lerner M, Iwasaki SD, the Dermagraft Diabetic Ulcer Study Group. Improved healing of diabetic foot ulcers after grafting with a living human dermal replacement. Wounds. 1999;11:77-84
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 Clinical Investigation of Dermagraft(R) in Patients With Plantar Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT01181440
- Acronym / sponsor ID
- ABH-DG-04-04-0694
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetic foot ulcer, Randomized trial, Clinical trial, Dermagraft, Conventional care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- OrganogenesisIndustry (pharma, biotech, devices)
- Study start
- Sep 1994
- Primary completion
- Jan 1997 (actual)
- Study completion
- Jan 1997 (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 plantar diabetic foot ulcers to receive conventional therapy (debridement, infection control, saline-moistened gauze dressings, and standardized off-weighting) alone or conventional therapy plus Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an absorbable polyglactin (Vicryl) mesh. Patients are evaluated weekly until Week 12, then every four weeks until Week 32.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dermagraft(R) and conventional care | Experimental | Device: Dermagraft(R) |
| Conventional care only | Other | Other: Conventional care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patient is 18 years old or older.
- Patient has a current diagnosis of NIDDM or IDDM.
- Patient's ulcer is present for a minimum of two weeks under the current Investigator's care
- The study ulcer has healed <50% in size during the two weeks leading up to randomization
- The study ulcer is on the plantar surface of the forefoot
Key exclusion criteria (13 listed)
- Patient has clinical evidence of gangrene on any part of the affected foot.
- The ulcer is over a Charcot deformity.
- The ulcer has a nondiabetic etiology.
- The ulcer has tunnels or sinus tracts that cannot be completely debrided.
- The patient's diabetes is uncontrolled and could interfere with the completion of the study.
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 |
|---|---|---|
| Dermagraft(R)Also: human fibroblast derived dermal substituteWeekly application of Dermagraft(R) with conventional care | Device | Dermagraft(R) and conventional care |
| Conventional careAlso: standard of care, off-loading, surgical debridement, wet-to-moist dressingWeekly application of conventional care | Other | Conventional care only |
Primary outcome
Proportion of patients with complete wound closure
Time frame: 12 weeks
5 secondary outcomes
Proportion of patients with complete wound closure
Time frame: 32 weeks
Time to reach 25%,50%,75%, and 100% of wound closure
Time frame: 32 weeks
Percent of wound healed
Time frame: 12 and 32 weeks
Wound characterization
Time frame: 32 weeks
Recurrence of the ulcer
Time frame: 32 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.
- Background: PubMed 9384327Naughton G, Mansbridge J, Gentzkow G. A metabolically active human dermal replacement for the treatment of diabetic foot ulcers. Artif Organs. 1997 Nov;21(11):1203-10. doi: 10.1111/j.1525-1594.1997.tb00476.x.
- Results publicationGentzkow GD, Jensen JL, Pollak RA, Kroeker RO, Lerner JM, Lerner M, Iwasaki SD, the Dermagraft Diabetic Ulcer Study Group. Improved healing of diabetic foot ulcers after grafting with a living human dermal replacement. Wounds. 1999;11:77-84
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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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.
Richard A Pollak, DPM principal investigator
San Antonio Podiatry Associates, San Antonio, TX
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(R) and Conventional care 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 14 inclusion and 13 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?
Proportion of patients with 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 NCT01181440, which also lists 2 linked publications.
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.