Foot Ulcer, DiabeticNCT02461641
NuShield/Affinity for the Treatment of Neuropathic Diabetic Foot Ulcers
A study testing NuShield and Affinity in people with Foot Ulcer, Diabetic, run by NuTech Medical, Inc at 7 sites in United States.
Trial summary
This study was designed to determine the heal rate of diabetic foot ulcers at 4 weeks, and complete closure at 8 and 12 weeks of patients treated with either NuShield or Affinity compared to standard care alone. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Foot Ulcer, Diabetic
- What is being tested?
- NuShield and Affinity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 7 sitesUnited States
- Study dates
- Mar 2015to 25 Oct 2018
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is or greater than 18 years old.
- Type 1 or Type 2 diabetes.
- Subject has plantar ulcers of greater than or equal to 4 weeks duration at presentation, unresponsive to standard wound care.
- Subject's ulcer size >0.5cm2 and < 20cm2 area post-debridement.
- Subject has well controlled glucose levels, with HbA1c < 10%.
- Subject has adequate lower extremity perfusion, with Ankle-Brachial Index > 0.8 (note: this is an ABI-equivalent, based on biphasic or triphasic color duplex - PVR or MRA. Diabetics often have peripheral vascular calcification or poorly compressible vessels resulting in abnormally high Ankle-Brachial Indices.) or dorsum transcutaneous oxygen test (TcPO2) > 30 mmHg. Presence of tibial and plantar pulses is preferred.
Show all 9Show fewer
- Subject should have no evidence of unresolved gross soft-tissue infection or boney pathology (i.e. osteomyelitis).
- Subject should have no evidence of underlying co-morbid conditions that would adversely affect wound healing such as: Cancer, Raynaud's syndrome, severe venous insufficiency or uncorrected arterial insufficiency, etc.
- Subject should not be on medications that compromise healing: cytotoxic chemotherapeutics, etc
Who cannot join
- Patients with evidence of skin cancer within or adjacent to the ulcer site.
- Patients who have signs and symptoms of boney pathology (i.e. osteomyelitis) following debridement.
- Patients with ulcers on the calcaneus.
- Patients who have significant arterial disease as determined by ABI, duplex Doppler sonography (PVR) or magnetic resonance angiography (MRA): Ankle-Brachial Index < 0.8 (note: this is an ABI-equivalent, based on biphasic or triphasic color duplex - PVR or MRA. Diabetics often have peripheral vascular calcification or poorly compressible vessels resulting in abnormally high ABIs); dorsum transcutaneous oxygen test (TcPO2) < 30 mmHg; absence of tibial or plantar pulses.
- Patients who have documented clinically significant medical conditions, which would impair wound healing. This includes:
- Renal impairment (creatinine >2.5 mg/dL);
Show all 24Show fewer
- Hepatic impairment (2XULN);
- Hematological disorders (abnormities of formed elements);
- Neurologic disorders resulting in significant impairment of sensory and motor functions as judged by the investigator;
- Patients with signs and symptoms of cellulitis;
- Patients with ulcers with sinus tracts associated with an ongoing infection;
- Patients with active deep vein thrombosis;
- Patients with uncontrolled diabetes, as demonstrated by increased HbA1C (> 10%);
- Immunocompromised patients (e.g., lymphoma, AIDS, myelodysplastic disorders)
- Patients with a history of basal cell carcinomas or actinically induced squamous cell carcinomas which have been effectively treated are not excluded, except if the skin cancer was in the exact location of the target ulcer.
- Patients with active systemic cancer receiving active cancer therapy
- Patients who are currently receiving, or have received within 1 week prior to study entry:
- Adriamycin (doxorubicin), bleomycin, serolimus (Rapamune, rapamycin) and anti-TNFα cytotoxic/immunosuppressive agents;
- Radiation therapy at the ulcer site;
- Topical growth factors at the target site (i.e., Regranex®).
- Patients enrolled in wound or drug investigational agent study for any disease within the past 4 weeks.
- Patients previously treated with amniotic membrane, PRP/PRFM, stem cell therapy, Apligraf, OrCel, Dermagraft, Graft Jacket, Oasis, stem cell therapy or any other advanced therapy at the target site for 1 month prior to enrollment.
- Pregnant or breast-feeding.
- Patients, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Richard C. Galperin, DPM, FAPWCA
Dallas, Texas, 75224
Wound Institute and Research Center
Dunmore, Pennsylvania, 18512
Limb Preservation Platform
Fresno, California, 93720
The Miller Care Group
Indianapolis, Indiana, 46234
Futuro clinical Trials, LLC
McAllen, Texas, 78501
The Wound Treatment Center
Opelousas, Louisiana, 70570
Temple University School of Pediatric Medicine
Philadelphia, Pennsylvania, 19107
About this study
Official title: The NuTech NuShield and Affinity Membrane Product Evaluation for the Treatment Neuropathic Diabetic Ulcers (DFU)
This study was designed to determine the heal rate of diabetic foot ulcers at 4 weeks, and complete closure at 8 and 12 weeks of patients treated with either NuShield or Affinity compared to standard care alone.
Read the detailed description
This is a three (3)-arm evaluation in 100 patients over 3 facilities with diabetic foot ulcers (DFU). Patients will be treated with NuShield or Affinity together with standard therapy or with standard care alone. For the purposes of this evaluation, standard therapy will consist of extensive debridement of nonviable tissue, saline-moistened non-occlusive dressing, off-loading to decrease pressure on extremity, aggressive treatment of infection and arterial revascularization if indicated. The patients will receive NuShield or Affinity plus standard therapy to determine optimal application method. The evaluation duration is 4 weeks with 8-week and 12-week follow-up visits. Patients with diabetic neuropathic foot ulcers of at least 4 weeks duration and free of clinical signs of infection at the time of treatment may be eligible for inclusion. At Week -1, each patient will undergo aggressive, surgical debridement. The site should be free of fibrin, necrotic and callous tissue. Digital imaging and planimetery of the target ulcer will be performed pre- and post initial debridement and at each subsequent visit as per the evaluation schedule. This evaluation is designed to investigate the potential of an allogeneic placental-derived amniotic membrane to accelerate healing of lower extremity DFU when used in conjunction with standard therapy. This potential will be measured as an increase in the rate of healing (daily decrease in percent wound area/volume compared to initial debrided ulcer area/volume) of patients treated with NuShield or Affinity plus standard wound care compared to patients treated with standard good wound care alone. Studies by Margolis and co-workers have demonstrated that the use of this surrogate marker, measured at 4 and 8 weeks of care, is predictive (>70%) of wound healing in patients with DFU at the 20th week of care. [Kantor 1998; Margolis 2003] The secondary endpoint will be patients achieving complete closure (100%) by week 12.
- Conditions
- Foot Ulcer, Diabetic
- Being tested
- NuShield, Affinity, Standard of Care
- Keywords
- amniotic tissue, diabetic foot ulcer, Affinity, NuShield
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NuShieldOther
NuShield is a sterilized dehydrated amnion chorion membrane patch.
AffinityOther
Affinity is a aseptically produced hypothermically stored amniotic membrane patch.
Standard of CareOther
Standard of Care for this study is defined as sharp debridement, moist wound dressing and offloading of the area using a DARCO shoe.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Other | Wounds will be treated with Standard of Care treatment which for the purpose of this study is defined as, extensive debridement of nonviable tissue, saline-moistened non-occlusive dressing and off-loading to decrease press on the extremity using a DARCO shoe. Receives: Other: Standard of Care |
| NuShield | Experimental | Wounds will be treated with Standard of Care treatment which for the purpose of this study is defined as, extensive debridement of nonviable tissue, saline-moistened non-occlusive dressing and off-loading to decrease press on the extremity using a DARCO shoe. In addition, wounds will be treated with a dehydrated amnion-chorion membrane, NuShield, for up to 4 weeks. Receives: Other: NuShield |
| Affinity | Experimental | Wounds will be treated with Standard of Care treatment which for the purpose of this study is defined as, extensive debridement of nonviable tissue, saline-moistened non-occlusive dressing and off-loading to decrease press on the extremity using a DARCO shoe. In addition, wounds will be treated with a fresh hypothermically stored amniotic membrane, Affinity, for up to 4 weeks. Receives: Other: Affinity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean adjusted heal rate
Percentage change in area method using ARANZ camera
Measured: 4 weeks
Secondary outcomes (2)
Extent of wound closure at 12 weeks
Percentage of wound closed at 12 weeks.
Measured: 12 weeks
Length of time to 100% healing of foot ulcer
Time (in days) to 100% healing-- complete closure in the absence of drainage
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startMar 2015
- Primary completion30 Apr 2018
- Study completion25 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot Ulcer, DiabeticStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuTech Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Organogenesis
- Responsible party
- Sponsor
- Investigators
- Katie Mowry, PhD, Study director, NuTech Medical, a division of Organogenesis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02461641
- Sponsor's protocol ID
- RD2014-08-03
- Status last verified
- Oct 2018
- First submitted
- 1 Jun 2015
- Last updated
- 22 Feb 2019
- 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 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The NuTech NuShield and Affinity Membrane Product Evaluation for the Treatment Neuropathic Diabetic Ulcers (DFU)
- ClinicalTrials.gov ID
- NCT02461641
- Acronym / sponsor ID
- RD2014-08-03
- Conditions
- Foot Ulcer, Diabetic
- Keywords
- amniotic tissue, diabetic foot ulcer, Affinity, NuShield
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- NuTech Medical, IncIndustry (pharma, biotech, devices)
- Collaborators
- Organogenesis
- Study start
- Mar 2015
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 25 Oct 2018 (actual)
- First posted
- 3 Jun 2015 (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 was designed to determine the heal rate of diabetic foot ulcers at 4 weeks, and complete closure at 8 and 12 weeks of patients treated with either NuShield or Affinity compared to standard care alone.
Detailed description
This is a three (3)-arm evaluation in 100 patients over 3 facilities with diabetic foot ulcers (DFU). Patients will be treated with NuShield or Affinity together with standard therapy or with standard care alone. For the purposes of this evaluation, standard therapy will consist of extensive debridement of nonviable tissue, saline-moistened non-occlusive dressing, off-loading to decrease pressure on extremity, aggressive treatment of infection and arterial revascularization if indicated. The patients will receive NuShield or Affinity plus standard therapy to determine optimal application method. The evaluation duration is 4 weeks with 8-week and 12-week follow-up visits. Patients with diabetic neuropathic foot ulcers of at least 4 weeks duration and free of clinical signs of infection at the time of treatment may be eligible for inclusion. At Week -1, each patient will undergo aggressive, surgical debridement. The site should be free of fibrin, necrotic and callous tissue. Digital imaging and planimetery of the target ulcer will be performed pre- and post initial debridement and at each subsequent visit as per the evaluation schedule. This evaluation is designed to investigate the potential of an allogeneic placental-derived amniotic membrane to accelerate healing of lower extremity DFU when used in conjunction with standard therapy. This potential will be measured as an increase in the rate of healing (daily decrease in percent wound area/volume compared to initial debrided ulcer area/volume) of patients treated with NuShield or Affinity plus standard wound care compared to patients treated with standard good wound care alone. Studies by Margolis and co-workers have demonstrated that the use of this surrogate marker, measured at 4 and 8 weeks of care, is predictive (>70%) of wound healing in patients with DFU at the 20th week of care. [Kantor 1998; Margolis 2003] The secondary endpoint will be patients achieving complete closure (100%) by week 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Other | Other: Standard of CareWounds will be treated with Standard of Care treatment which for the purpose of this study is defined as, extensive debridement of nonviable tissue, saline-moistened non-occlusive dressing and off-loading to decrease press on the extremity using a DARCO shoe. |
| NuShield | Experimental | Other: NuShieldWounds will be treated with Standard of Care treatment which for the purpose of this study is defined as, extensive debridement of nonviable tissue, saline-moistened non-occlusive dressing and off-loading to decrease press on the extremity using a DARCO shoe. In addition, wounds will be treated with a dehydrated amnion-chorion membrane, NuShield, for up to 4 weeks. |
| Affinity | Experimental | Other: AffinityWounds will be treated with Standard of Care treatment which for the purpose of this study is defined as, extensive debridement of nonviable tissue, saline-moistened non-occlusive dressing and off-loading to decrease press on the extremity using a DARCO shoe. In addition, wounds will be treated with a fresh hypothermically stored amniotic membrane, Affinity, for up to 4 weeks. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject is or greater than 18 years old.
- Type 1 or Type 2 diabetes.
- Subject has plantar ulcers of greater than or equal to 4 weeks duration at presentation, unresponsive to standard wound care.
- Subject's ulcer size >0.5cm2 and < 20cm2 area post-debridement.
- Subject has well controlled glucose levels, with HbA1c < 10%.
Key exclusion criteria (24 listed)
- Patients with evidence of skin cancer within or adjacent to the ulcer site.
- Patients who have signs and symptoms of boney pathology (i.e. osteomyelitis) following debridement.
- Patients with ulcers on the calcaneus.
- Patients who have significant arterial disease as determined by ABI, duplex Doppler sonography (PVR) or magnetic resonance angiography (MRA): Ankle-Brachial Index < 0.8 (note: this is an ABI-equivalent, based on biphasic or triphasic color duplex - PVR or MRA. Diabetics often have peripheral vascular calcification or poorly compressible vessels resulting in abnormally high ABIs); dorsum transcutaneous oxygen test (TcPO2) < 30 mmHg; absence of tibial or plantar pulses.
- Patients who have documented clinically significant medical conditions, which would impair wound healing. This includes:
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 |
|---|---|---|
| NuShieldNuShield is a sterilized dehydrated amnion chorion membrane patch. | Other | NuShield |
| AffinityAffinity is a aseptically produced hypothermically stored amniotic membrane patch. | Other | Affinity |
| Standard of CareStandard of Care for this study is defined as sharp debridement, moist wound dressing and offloading of the area using a DARCO shoe. | Other | Standard of Care |
Primary outcome
Mean adjusted heal rate
Time frame: 4 weeks
Percentage change in area method using ARANZ camera
2 secondary outcomes
Extent of wound closure at 12 weeks
Time frame: 12 weeks
Length of time to 100% healing of foot ulcer
Time frame: Up to 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 22 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Foot Ulcer, Diabetic
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.
Katie Mowry, PhD study director
NuTech Medical, a division of Organogenesis
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NuShield and Affinity in people with Foot Ulcer, Diabetic, run by NuTech Medical, Inc at 7 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 24 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 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Mean adjusted heal rate (time frame: 4 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 22 Feb 2019.