Diabetic Foot UlcersNCT02880592
Effect of Fresh Amniotic Membrane in the Treatment of Diabetic Foot Ulcers
A study testing Affinity Allograft in people with Diabetic Foot Ulcers, run by Organogenesis at 8 sites in United States.
Trial summary
This is a multi-center, randomized controlled trial designed to evaluate the use of fresh hypothermically stored human amniotic membrane (Affinity; fHSAM) to determine if addition of fHSAM to standard of care (SOC) results in faster healing of Wagner grade 1 and 2 DFUs compared to SOC alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcers
- What is being tested?
- Affinity Allograft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 8 sitesUnited States
- Study dates
- Aug 2016to 1 Apr 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
- At least 18 years old.
- Presence of a diabetic foot ulcer, Wagner 1 or 2 grade , extending at least through the dermis or subcutaneous tissue and may involve the tendon or muscle, on any aspect of the foot provided it is below the medial aspect of the malleolus.
- The index ulcer will be the largest ulcer if 2 or more DFUs are present with the same Wagner grade and will be the only one in the study. If other ulcerations are present on the same foot they have to be more than 2 cm apart from the index ulcer.
- Index ulcer (i.e. current episode of ulceration) has been present for greater than 4 weeks prior to the initial screening visit and less than 1 year.
- Study ulcer is a minimum of 0.75 cm2 and a maximum of 25 cm2 at first treatment visit.
- Adequate circulation to the affected foot as demonstrated by a dorsum transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg, or an ABI between 0.7 and 1.3 within 3 months of the first Screening Visit,or TBI of > 6 within 3 months of the first Screening Visit .
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- The target ulcer has been offloaded for at least 14 days prior to randomization.
- Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence).
- Subject understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
Who cannot join
- Study ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes.
- Index ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer.
- Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids >10 mg daily), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to first Screening Visit, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
- Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding the first Screening Visit.
- History of radiation at the ulcer site.
- Index ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) within the last 30 days preceding the first Screening Visit or will need to be treated with any prohibited therapies.
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- Affected extremity requiring negative pressure wound therapy or subject requiring hyperbaric oxygen during the course of the trial.
- Presence of any condition(s) which seriously compromises the subject's ability to complete this study, or has a known history of poor adherence with medical treatment.
- Osteomyelitis or bone infection of the affected foot as verified by X-ray within 30 days prior to Randomization.
- Subject is pregnant or breast feeding.
- Presence of diabetes with poor metabolic control as documented with an HgA1c > 12.0 within last 90 days.
- Patients with end stage renal disease.
- Index ulcer has reduced in area by 20% or more after 14 days of standard of care from the first screening visit (S1) to the TV1/randomization visit.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Summit Health Hospital
Chambersburg, Pennsylvania, 17201
Henry Ford Macomb Hospital
Clinton Township, Michigan, 48038
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
This is a multi-center, randomized controlled trial designed to evaluate the use of fresh hypothermically stored human amniotic membrane (Affinity; fHSAM) to determine if addition of fHSAM to standard of care (SOC) results in faster healing of Wagner grade 1 and 2 DFUs compared to SOC alone.
Read the detailed description
This study is a multi-center, randomized, controlled open-label study designed to evaluate the safety and effectiveness of Affinity fresh amniotic membrane plus standard of care therapy (SOC) versus SOC in the treatment of diabetic foot ulcers.
The standard of care therapy in this study is offloading of the DFU, appropriate sharp or surgical debridement, and aggressive infection management. 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 study will have two phases: Screening and Treatment.
The Screening Phase (1 -14 days) is designed to determine whether subjects are eligible to proceed to the Treatment Phase of the study and consists of a series of screening assessments designed to determine eligibility. At the first Screening Phase Visit, the Investigator will select the study (target) ulcer. Each subject will have only one DFU selected as the study (target) ulcer. In the situation in which a subject has more than one DFU at the S1 visit, the Investigator will select the largest DFU that meets the eligibility criteria of the protocol as the study (target) ulcer. Subjects whose target ulcer has been treated with SOC for 2 weeks are eligible to enter the treatment phase immediately once all of the inclusion and exclusion criteria are met. If the ulcer has not received SOC, the subject should be placed into SOC and enrolled in the study after 14 days of offloading.
The Treatment Phase (12 weeks) begins with a series of assessments designed to confirm the subjects' continued eligibility. Investigators will debride the ulcer, if required. Subjects whose ulcers continue to meet eligibility criteria will then be randomized to 1 of 2 groups: (1) standard of care plus weekly application of fHSAM for up to 4 weeks and thereafter per treatment guidelines (2) standard of care. 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 photos. Safety evaluations during the Treatment Phase will consist of adverse event assessments at each visit. Subject will be seen weekly (± 3 days) until the ulcer is healed or study exit if the study ulcer area has not been reduced by at least 40% within 6 weeks, or 1 week after last application treatment week 12.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- Affinity Allograft, Standard of 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.
Affinity AllograftOther
fresh hypothermically stored human amniotic membrane
Standard of careOther
offloading, debridement, infection management using appropriate dressings
| Study group | Role | What they receive |
|---|---|---|
| Fresh amniotic membrane/standard of care | Experimental | This group will receive the Affinity Allograft and standard of care. Receives: Other: Affinity Allograft; Other: Standard of care |
| Standard of Care | Active comparator | This group will receive standard of care for diabetic foot ulcers that includes offloading of the diabetic foot ulcer, debridement, and infection management using the appropriate dressings. Receives: Other: Standard of care |
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
Time to initial closure of diabetic foot ulcers will be compared between the two groups.
Measured: 12 weeks
Secondary outcomes (4)
Proportion of healed wounds
The proportion of healed wounds at 12 weeks comparing the two groups.
Measured: 12 weeks
Proportion of healed wounds
The proportion of healed wounds at 4 weeks comparing the two groups.
Measured: 4 weeks
Quality of Life measurement
Subjects will complete the W-QoL questionnaire at baseline and 12 weeks. Changes in scores will be compared between the two groups.
Measured: baseline and 12 weeks
Incidence of adverse events
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 posted26 Aug 2016 (estimated)
- Study startAug 2016
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcersStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organogenesis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- SerenaGroup, Inc.
- Responsible party
- Sponsor
- Investigators
- Katie Mowry, PhD, Study director, NuTech Medical, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880592
- Sponsor's protocol ID
- NT-DFU-AFF-01
- Status last verified
- Feb 2020
- First submitted
- 23 Aug 2016
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- 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
- ClinicalTrials.gov ID
- NCT02880592
- Acronym / sponsor ID
- NT-DFU-AFF-01
- Conditions
- Diabetic Foot Ulcers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- OrganogenesisIndustry (pharma, biotech, devices)
- Collaborators
- SerenaGroup, Inc.
- Study start
- Aug 2016
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 26 Aug 2016 (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 is a multi-center, randomized controlled trial designed to evaluate the use of fresh hypothermically stored human amniotic membrane (Affinity; fHSAM) to determine if addition of fHSAM to standard of care (SOC) results in faster healing of Wagner grade 1 and 2 DFUs compared to SOC alone.
Detailed description
This study is a multi-center, randomized, controlled open-label study designed to evaluate the safety and effectiveness of Affinity fresh amniotic membrane plus standard of care therapy (SOC) versus SOC in the treatment of diabetic foot ulcers.
The standard of care therapy in this study is offloading of the DFU, appropriate sharp or surgical debridement, and aggressive infection management. 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 study will have two phases: Screening and Treatment.
The Screening Phase (1 -14 days) is designed to determine whether subjects are eligible to proceed to the Treatment Phase of the study and consists of a series of screening assessments designed to determine eligibility. At the first Screening Phase Visit, the Investigator will select the study (target) ulcer. Each subject will have only one DFU selected as the study (target) ulcer. In the situation in which a subject has more than one DFU at the S1 visit, the Investigator will select the largest DFU that meets the eligibility criteria of the protocol as the study (target) ulcer. Subjects whose target ulcer has been treated with SOC for 2 weeks are eligible to enter the treatment phase immediately once all of the inclusion and exclusion criteria are met. If the ulcer has not received SOC, the subject should be placed into SOC and enrolled in the study after 14 days of offloading.
The Treatment Phase (12 weeks) begins with a series of assessments designed to confirm the subjects' continued eligibility. Investigators will debride the ulcer, if required. Subjects whose ulcers continue to meet eligibility criteria will then be randomized to 1 of 2 groups: (1) standard of care plus weekly application of fHSAM for up to 4 weeks and thereafter per treatment guidelines (2) standard of care. 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 photos. Safety evaluations during the Treatment Phase will consist of adverse event assessments at each visit. Subject will be seen weekly (± 3 days) until the ulcer is healed or study exit if the study ulcer area has not been reduced by at least 40% within 6 weeks, or 1 week after last application treatment week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fresh amniotic membrane/standard of care | Experimental | Other: Affinity Allograft, Other: Standard of careThis group will receive the Affinity Allograft and standard of care. |
| Standard of Care | Active comparator | Other: Standard of careThis group will receive standard of care for diabetic foot ulcers that includes offloading of the diabetic foot ulcer, debridement, and infection management using the appropriate dressings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- At least 18 years old.
- Presence of a diabetic foot ulcer, Wagner 1 or 2 grade , extending at least through the dermis or subcutaneous tissue and may involve the tendon or muscle, on any aspect of the foot provided it is below the medial aspect of the malleolus.
- The index ulcer will be the largest ulcer if 2 or more DFUs are present with the same Wagner grade and will be the only one in the study. If other ulcerations are present on the same foot they have to be more than 2 cm apart from the index ulcer.
- Index ulcer (i.e. current episode of ulceration) has been present for greater than 4 weeks prior to the initial screening visit and less than 1 year.
- Study ulcer is a minimum of 0.75 cm2 and a maximum of 25 cm2 at first treatment visit.
Key exclusion criteria (13 listed)
- Study ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes.
- Index ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer.
- Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids >10 mg daily), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to first Screening Visit, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
- Subjects on any investigational drug(s) or therapeutic device(s) within 30 days preceding the first Screening Visit.
- History of radiation at the ulcer site.
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 Allograftfresh hypothermically stored human amniotic membrane | Other | Fresh amniotic membrane/standard of care |
| Standard of careoffloading, debridement, infection management using appropriate dressings | Other | Fresh amniotic membrane/standard of care, Standard of Care |
Primary outcome
Time to initial closure of diabetic foot ulcer
Time frame: 12 weeks
Time to initial closure of diabetic foot ulcers will be compared between the two groups.
4 secondary outcomes
Proportion of healed wounds
Time frame: 12 weeks
Proportion of healed wounds
Time frame: 4 weeks
Quality of Life measurement
Time frame: baseline and 12 weeks
Incidence of adverse events
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
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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.
Katie Mowry, PhD study director
NuTech Medical, Inc
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Affinity Allograft in people with Diabetic Foot Ulcers, run by Organogenesis at 8 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 9 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 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 8 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.