Diabetic Foot UlcerNCT03205436
Affinity Prospective Diabetic Foot Trial Crossover Group
A study testing Affinity human amniotic membrane in people with Diabetic Foot Ulcer, run by Organogenesis at 6 sites in United States.
Trial summary
This study is an extension of the randomized controlled trial NT-DFU-AFF-01. Subjects that were randomized to the Standard of Care group will be able to crossover to the NT-DFU-AFF-02 trial and receive Affinity fHSAM if certain criteria are met. 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?
- Affinity human amniotic membrane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 May 2017to 15 Aug 2019
- Phase
- Interventional
- 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
- A percentage area reduction of less than 40% after having received 6 weeks of treatment with SOC in the NT-DFU-01 trial.
- Subject understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
- Subject has read and signed the IRB/IEC approved Informed Consent Form.
- Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
- At least 18 years old.
Who cannot join
- Failure to complete 6 weeks of SOC in the original NT-DFU-01 study
- Any AE or SAE that occurred during the NT-DFU-01 study, which, in the opinion of the investigator would preclude the subject successfully having Affinity applied for up to 12 weeks.
- Subject is unlikely to complete a regimen of Affinity and SOC for up to 12 weeks due to personal reasons.
- Subject is pregnant or breast feeding.
- Osteomyelitis or bone infection of the affected foot as assessed by X-ray.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
The Foot and Ankle Wellness Center
Ford City, Pennsylvania, 16226
Armstrong County Memorial Hospital
Kittanning, Pennsylvania, 16201
GF Professional Research
Miami Lakes, Florida, 33016
Barry University Clinical Research
North Miami Beach, Florida, 33169
SerenaGroup Research Institute
Pittsburgh, Pennsylvania, 15222
Martin Foot and Ankle
York, Pennsylvania, 17402
About this study
Official title: A Multi-center, Randomized Controlled Clinical Trial Evaluating the Effect of Fresh Amniotic Membrane in the Treatment of Diabetic Foot Ulcers: Crossover Group From Standard of Care
This study is an extension of the randomized controlled trial NT-DFU-AFF-01. Subjects that were randomized to the Standard of Care group will be able to crossover to the NT-DFU-AFF-02 trial and receive Affinity fHSAM if certain criteria are met.
Read the detailed description
This study is an extension of the randomized controlled trial NT-DFU-AFF-01 in which subjects were randomized to SOC for 12 weeks or SOC and fresh hypothermically stored human amniotic membrane (Affinity; fHSAM) for 12 weeks to determine if addition of fHSAM to SOC results in faster healing of Wagner grade 1 and 2 DFUs compared to SOC alone.
At 6 weeks, patients from this RCT (NT-DFU-AFF-01) with study DFUs that have not been reduced in area by at least 40% will be exited from the study and considered treatment failures. This group (Group 2C) will constitute the active population in this single arm study (NT-DFU-AFF-02). Study wounds will receive up to 12 weeks of continuing SOC and fHSAM.
The standard of care therapy in this study is offloading of the DFU, appropriate sharp or surgical debridement, and aggressive infection management with the use of appropriate dressings (defined later in the protocol). A number of offloading systems are commercially available. The choice of offloading will be at the discretion of the principal investigator but should be total contact casting, fixed ankle walker boot, or equivalent device to the fixed ankle walker boot.
The Screening Phase (1 day) consists of a series of screening assessments designed to determine eligibility followed by, for those who meet the eligibility criteria (described in more detail below), treatment. At the Screening Visit (S1), written informed consent from the subject will be obtained by the Investigator or suitably qualified designee before the performance of any other protocol-specific procedure. The Screening Period is designed to determine whether subjects are eligible to proceed to the Treatment Phase of the study.
The Treatment Phase (12 Weeks) begins on the same day as the screening visit. During the Treatment Phase, subjects will be evaluated on a weekly basis. Efficacy evaluations each week will include Investigator assessment of ulcer healing and measurements of ulcer size using digital photographic planimetry. Safety evaluations during the Treatment Phase will consist of adverse event assessments at each visit.
Subjects whose ulcers do not achieve closure at 12 weeks or who experience an amputation will be deemed treatment failures.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Affinity human amniotic membrane
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Affinity human amniotic membraneOther
fresh hypothermically stored human amniotic membrane
| Study group | Role | What they receive |
|---|---|---|
| Graft | Experimental | Affinity human amniotic membrane Receives: Other: Affinity human amniotic membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to initial closure of diabetic foot ulcer
Measured: 12 weeks
Secondary outcomes (3)
Proportion of healed wounds
Measured: 12 weeks
Mean wastage of graft
healed wounds only
Measured: 12 weeks
Mean cost to heal
healed wounds only
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 posted2 Jul 2017
- Study start1 May 2017
- Primary completion15 Jun 2019
- Study completion15 Aug 2019
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organogenesis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SerenaGroup, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205436
- Sponsor's protocol ID
- NT-DFU-AFF-02
- Status last verified
- Feb 2020
- First submitted
- 28 Jun 2017
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized Controlled Clinical Trial Evaluating the Effect of Fresh Amniotic Membrane in the Treatment of Diabetic Foot Ulcers: Crossover Group From Standard of Care
- ClinicalTrials.gov ID
- NCT03205436
- Acronym / sponsor ID
- NT-DFU-AFF-02
- Conditions
- Diabetic Foot Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- OrganogenesisIndustry (pharma, biotech, devices)
- Collaborators
- SerenaGroup, Inc.
- Study start
- 1 May 2017 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 15 Aug 2019 (actual)
- First posted
- 2 Jul 2017 (actual)
- 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 is an extension of the randomized controlled trial NT-DFU-AFF-01. Subjects that were randomized to the Standard of Care group will be able to crossover to the NT-DFU-AFF-02 trial and receive Affinity fHSAM if certain criteria are met.
Detailed description
This study is an extension of the randomized controlled trial NT-DFU-AFF-01 in which subjects were randomized to SOC for 12 weeks or SOC and fresh hypothermically stored human amniotic membrane (Affinity; fHSAM) for 12 weeks to determine if addition of fHSAM to SOC results in faster healing of Wagner grade 1 and 2 DFUs compared to SOC alone.
At 6 weeks, patients from this RCT (NT-DFU-AFF-01) with study DFUs that have not been reduced in area by at least 40% will be exited from the study and considered treatment failures. This group (Group 2C) will constitute the active population in this single arm study (NT-DFU-AFF-02). Study wounds will receive up to 12 weeks of continuing SOC and fHSAM.
The standard of care therapy in this study is offloading of the DFU, appropriate sharp or surgical debridement, and aggressive infection management with the use of appropriate dressings (defined later in the protocol). A number of offloading systems are commercially available. The choice of offloading will be at the discretion of the principal investigator but should be total contact casting, fixed ankle walker boot, or equivalent device to the fixed ankle walker boot.
The Screening Phase (1 day) consists of a series of screening assessments designed to determine eligibility followed by, for those who meet the eligibility criteria (described in more detail below), treatment. At the Screening Visit (S1), written informed consent from the subject will be obtained by the Investigator or suitably qualified designee before the performance of any other protocol-specific procedure. The Screening Period is designed to determine whether subjects are eligible to proceed to the Treatment Phase of the study.
The Treatment Phase (12 Weeks) begins on the same day as the screening visit. During the Treatment Phase, subjects will be evaluated on a weekly basis. Efficacy evaluations each week will include Investigator assessment of ulcer healing and measurements of ulcer size using digital photographic planimetry. Safety evaluations during the Treatment Phase will consist of adverse event assessments at each visit.
Subjects whose ulcers do not achieve closure at 12 weeks or who experience an amputation will be deemed treatment failures.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Graft | Experimental | Other: Affinity human amniotic membraneAffinity human amniotic membrane |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A percentage area reduction of less than 40% after having received 6 weeks of treatment with SOC in the NT-DFU-01 trial.
- Subject understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
- Subject has read and signed the IRB/IEC approved Informed Consent Form.
- Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
- At least 18 years old.
Key exclusion criteria (5 listed)
- Failure to complete 6 weeks of SOC in the original NT-DFU-01 study
- Any AE or SAE that occurred during the NT-DFU-01 study, which, in the opinion of the investigator would preclude the subject successfully having Affinity applied for up to 12 weeks.
- Subject is unlikely to complete a regimen of Affinity and SOC for up to 12 weeks due to personal reasons.
- Subject is pregnant or breast feeding.
- Osteomyelitis or bone infection of the affected foot as assessed by X-ray.
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 |
|---|---|---|
| Affinity human amniotic membranefresh hypothermically stored human amniotic membrane | Other | Graft |
Primary outcome
Time to initial closure of diabetic foot ulcer
Time frame: 12 weeks
3 secondary outcomes
Proportion of healed wounds
Time frame: 12 weeks
Mean wastage of graft
Time frame: 12 weeks
Mean cost to heal
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 19 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Diabetic Foot Ulcer
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Evaluation of the Safety and Efficacy of Live ASCs in the Treatment of Diabetic Foot Syndrome.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Affinity human amniotic membrane in people with Diabetic Foot Ulcer, run by Organogenesis at 6 sites 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 5 inclusion and 5 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 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
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?
Time to initial closure of diabetic foot ulcer (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 19 Feb 2020.