- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03205436
Affinity Prospective Diabetic Foot Trial Crossover Group
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Miami Lakes, Florida, United States, 33016
- GF Professional Research
-
North Miami Beach, Florida, United States, 33169
- Barry University Clinical Research
-
-
Pennsylvania
-
Ford City, Pennsylvania, United States, 16226
- The Foot and Ankle Wellness Center
-
Kittanning, Pennsylvania, United States, 16201
- Armstrong County Memorial Hospital
-
Pittsburgh, Pennsylvania, United States, 15222
- SerenaGroup Research Institute
-
York, Pennsylvania, United States, 17402
- Martin Foot and Ankle
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Graft
Affinity human amniotic membrane
|
fresh hypothermically stored human amniotic membrane
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to initial closure of diabetic foot ulcer
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of healed wounds
Time Frame: 12 weeks
|
12 weeks
|
|
Mean wastage of graft
Time Frame: 12 weeks
|
healed wounds only
|
12 weeks
|
Mean cost to heal
Time Frame: 12 weeks
|
healed wounds only
|
12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NT-DFU-AFF-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetic Foot Ulcer
-
University of MinnesotaRecruitingDiabetes Mellitus | Foot Ulcer | Ulcer | Diabetic Foot Ulcer | Foot Ulcer, Diabetic | Ulcer Foot | Ulcer, Leg | Ankle UlcerUnited States
-
Community Pharmacology Services LtdKeneric HealthcareNot yet recruitingDiabetic Foot Ulcer | Diabetic Foot Ulcer Neuropathic | Diabetic Foot Ulcer Ischemic
-
University of PadovaUnknownDiabetic Foot | Diabetic Foot Ulcer | Diabetic Foot Infection | Diabetic Foot Ulcer Neuropathic | Deformities FootItaly
-
Johns Hopkins UniversityWithdrawnDiabetic Foot | Diabetic Foot Ulcer | Diabetic Foot Infection | Diabetic Foot Ulcer Mixed | Vascular Ulcer (Arterial or Venous Including Diabetic Ulcers Not Located on the Foot)
-
Corporacion Parc TauliCompletedDiabetic Foot Ulcer | Diabetic Foot Ulcer NeuropathicPakistan
-
Baylor College of MedicineLifeNet HealthCompletedDiabetic Foot Ulcer | Deep Diabetic Foot UlcerUnited States
-
ETS Wound Care, LLCProfessional Education and Research InstituteCompletedDiabetic Foot | Diabetic Foot Ulcer | Ulcer FootUnited States
-
Exciton Technologies Inc.CompletedDiabetic Foot Ulcer | Diabetic Foot Infection | Non-healing Diabetic Foot UlcerCanada
-
National and Kapodistrian University of AthensTerminatedDiabetic Foot | Chronic Diabetic Foot Ulcer of Right Foot | Neuropathic Foot Ulcer | Chronic Diabetic Ulcer of Left Foot (Diagnosis)Greece
-
University of the PunjabHigher Education Commission (Pakistan); Centre of Excellence in Molecular Biology... and other collaboratorsRecruitingDiabetes Mellitus | Diabetic Foot | Foot Ulcer | Diabetes Complications | Diabetic Foot Ulcer | Diabetic Foot Infection | Diabetic Foot Ulcer Neuropathic | Foot Ulcer Due to Type 1 Diabetes Mellitus | Foot Ulcer Due to Type 2 Diabetes Mellitus | Chronic Diabetic Ulcer of Left Foot | Chronic Diabetic Foot...Pakistan
Clinical Trials on Affinity human amniotic membrane
-
University of UtahUnknownAtrial FibrillationUnited States
-
Federal University of São PauloUnknown
-
University of AlexandriaCompleted
-
Liventa BioscienceWithdrawnDiabetic Foot Ulcers | Wound CareUnited States
-
Louisiana State University Health Sciences Center...UnknownTrauma | Soft Tissue Injuries | Wounds | Injury | Limb SalvageUnited States
-
Tides MedicalUnknownFoot Ulcer, Diabetic | Venous UlcerUnited States
-
Andalusian Initiative for Advanced Therapies -...Iniciativa Andaluza en Terapias AvanzadasCompletedSevere Trophic Corneal Ulcers Refractory to Conventional Treatment | Sequelae of Previous Trophic Corneal UlcersSpain
-
Orthopedic Foot and Ankle Center, OhioTerminatedTendon TearsUnited States
-
Klinikum Chemnitz gGmbHTechnische Universität DresdenCompletedCorneal Ulcers | Corneal MeltingGermany
-
Red de Terapia CelularUniversidad de Murcia; Hospital Universitario Virgen de la Arrixaca; MurciaSalud and other collaboratorsCompleted