Diabetic FootPhase 3NCT00512538
Apligraf Versus Standard Therapy in the Treatment of Diabetic Foot Ulcers
A Phase 3 study testing Bi-layered cell therapy (Apligraf) in people with Diabetic Foot, run by Organogenesis.
Trial summary
The purpose of this study is to determine the ability of Apligraf to improve the time to and incidence of complete wound closure of diabetic foot ulcers, as compared to diabetic foot ulcers treated with standard therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Foot
- What is being tested?
- Bi-layered cell therapy (Apligraf)
- Type of treatment
- Medical device
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- Oct 2000to Sep 2002
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diabetic ulcer of primarily neuropathic origin on the plantar region of the forefoot
- ulcer extending through the dermis but without sinus tract, tendon, capsule or bone exposure
- ulcer present for at least 2 weeks and measuring 1- 16 cm2
- diminished sensesation on target extremity/foot
- ulcer is not infected
- Type 1 or 2 diabetes with adequate glycemic control
- Adequate vascular supply to the target extremity
Who cannot join
- Charcot foot
- Non-neuropathic ulcers
- Skin cancer within or adjacent to the target ulcer
- Osteomyelitis or an infected ulcer
- Clinically significant medical condition that would impair wound healing
- Females who are pregnant
- Received within 4 weeks of study entry systemic corticosteriods, immunosuppresive agents, radiation therapy or chemotherapy
About this study
Official title: A Randomized, Open-Label, Multi-Center Study to Compare the Safety and Efficacy of Apligraf Versus Standard Therapy (i.e., Saline Moistened Dressing Regimen) in the Treatment of Diabetic (Primarily Neuropathic) Foot Ulcers
The purpose of this study is to determine the ability of Apligraf to improve the time to and incidence of complete wound closure of diabetic foot ulcers, as compared to diabetic foot ulcers treated with standard therapy.
Read the detailed description
Ulceration of the diabetic foot is a result of multiple problems including repetitive stress on a neuropathic or insensate area that is often associated with an underlying bony prominence. By healing diabetic foot ulcers quickly the risks of infection, osteomyelitis (infeciton of the bone) and limb loss can be reduced.
This study will evaluate the ability of Apligraf to heal diabetic foot ulcers that have been present for at least 2 weeks and are between 1 - 16 cm2 in area. Patients will be randomized to either (50:50 chance) treatment with Apligraf or a saline moistened dressing regimen (standard therapy). All patients will receive standard cares for the ulcers which includes debridement, orthotics and off-loading throughout the treatment period.
- Conditions
- Diabetic Foot
- Being tested
- Bi-layered cell therapy (Apligraf)
- Keywords
- Diabetic foot
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bi-layered cell therapy (Apligraf)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete wound healing (full epithelialization with no drainage)
Measured: through 12 weeks
Secondary outcomes (1)
Incidence of complete healing
Measured: at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2007 (estimated)
- Study startOct 2000
- Study completionSep 2002
Why it stopped: Interruption of business relations between Study Sponsor and Device Manufacturer
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies 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
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organogenesis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Michael E Edmonds, MD, Principal investigator, Diabetic Foot Clinic, Kings College Hospital, London UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512538
- Sponsor's protocol ID
- CGS0769 B304
- Status last verified
- Aug 2007
- First submitted
- 3 Aug 2007
- Last updated
- 7 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Multi-Center Study to Compare the Safety and Efficacy of Apligraf Versus Standard Therapy (i.e., Saline Moistened Dressing Regimen) in the Treatment of Diabetic (Primarily Neuropathic) Foot Ulcers
- ClinicalTrials.gov ID
- NCT00512538
- Acronym / sponsor ID
- CGS0769 B304
- Conditions
- Diabetic Foot
- Keywords
- Diabetic foot
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interruption of business relations between Study Sponsor and Device Manufacturer
- Enrolment
- 82 participants (actual)
- Lead sponsor
- OrganogenesisIndustry (pharma, biotech, devices)
- Study start
- Oct 2000
- Study completion
- Sep 2002 (actual)
- First posted
- 7 Aug 2007 (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 purpose of this study is to determine the ability of Apligraf to improve the time to and incidence of complete wound closure of diabetic foot ulcers, as compared to diabetic foot ulcers treated with standard therapy.
Detailed description
Ulceration of the diabetic foot is a result of multiple problems including repetitive stress on a neuropathic or insensate area that is often associated with an underlying bony prominence. By healing diabetic foot ulcers quickly the risks of infection, osteomyelitis (infeciton of the bone) and limb loss can be reduced.
This study will evaluate the ability of Apligraf to heal diabetic foot ulcers that have been present for at least 2 weeks and are between 1 - 16 cm2 in area. Patients will be randomized to either (50:50 chance) treatment with Apligraf or a saline moistened dressing regimen (standard therapy). All patients will receive standard cares for the ulcers which includes debridement, orthotics and off-loading throughout the treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- diabetic ulcer of primarily neuropathic origin on the plantar region of the forefoot
- ulcer extending through the dermis but without sinus tract, tendon, capsule or bone exposure
- ulcer present for at least 2 weeks and measuring 1- 16 cm2
- diminished sensesation on target extremity/foot
- ulcer is not infected
Key exclusion criteria (7 listed)
- Charcot foot
- Non-neuropathic ulcers
- Skin cancer within or adjacent to the target ulcer
- Osteomyelitis or an infected ulcer
- Clinically significant medical condition that would impair wound healing
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 |
|---|---|---|
| Bi-layered cell therapy (Apligraf) | Device | – |
Primary outcome
Time to complete wound healing (full epithelialization with no drainage)
Time frame: through 12 weeks
1 secondary outcome
Incidence of complete healing
Time frame: at 12 weeks
Results and safety
The study was stopped early (reason given: Interruption of business relations between Study Sponsor and Device Manufacturer). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2007.
Related trials for Diabetic Foot
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
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.
Michael E Edmonds, MD principal investigator
Diabetic Foot Clinic, Kings College Hospital, London UK
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bi-layered cell therapy (Apligraf) in people with Diabetic Foot, run by Organogenesis.
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 7 inclusion and 7 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 7 Aug 2007. 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.
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 was stopped early (reason given: Interruption of business relations between Study Sponsor and Device Manufacturer). 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?
Time to complete wound healing (full epithelialization with no drainage) (time frame: through 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 7 Aug 2007.