Diabetic Foot UlcersPhase 4TADNCT02344329
A Comparison of TCC-EZ Using Human Amnion Allograft vs TCC-EZ and Standard Wound Care in Treating Diabetic Foot Ulcers.
A Phase 4 study testing Topical wound dressing, Human Amnion Allograft and usual wound care in people with Diabetic Foot Ulcers and Diabetes, run by University of North Dakota at 1 site in United States.
Trial summary
A Comparison of AmnioExcel® and Total Contact Casting (TCC-EZ) Versus Standard Wound Care and TCC-EZ in Treating Diabetic Foot Ulcers Best practice is to treat DFUs with standardized care and, if unsuccessful, use advanced modalities. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot Ulcers, Diabetes
- What is being tested?
- Topical wound dressing, Human Amnion Allograft and usual wound care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Nov 2017
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects will be included if they are 18 years of age or older
- have a diagnosis of diabetes type 1 or 2
- random blood sugar of 450 or < and HbA1c of 15% or < drawn quarterly prior to study
- the ulcer has been present for a minimum of 2 weeks under the current investigators care
- the foot ulcer is on the plantar surface of the forefoot or heel and > 0.5cm2 in size at day 0
- patient's ulcer extends through the dermis into subcutaneous tissue but without exposure of bone or joint capsule classified as a grade 2 or 3 DFU using the University of Texas diabetic wound classification system
- ulcer is free of necrotic debris and appears to be made up of healthy vascularized tissue
- and subject's foot has evidence of adequate perfusion with an ankle-brachial index of > 0.7 and < 1.2.-
Who cannot join
- Subjects younger that 18 years of age
- no current diagnosis of diabetes type 1 or 2
- has uncontrolled hyperglycemia random blood sugar of > 450 mg/dl
- HbA1c > 15%
- gangrene present on any part of the affected foot
- ulcer's total surface area is > 20cm2
Show all 9Show fewer
- ulcer has decreased or increased in size by 50% or more during the screening period
- presence of non-study ulcer located within 7.0 cm of the study ulcer at the beginning of the study day 0
- and evidence of infection determined by the provider.
Trial locations and contacts
1 site in 1 country.
United States1 site
Altru Health System
Grand Forks, North Dakota, 58202
About this study
Official title: A Comparison of Total Contact Casting (TCC-EZ) Using Human Amnion Allograft (AmnioExcel) Versus Total Contact Casting (TCC-EZ) and Standard Wound Care in Treating Diabetic Foot Ulcers (TAD)
A Comparison of AmnioExcel® and Total Contact Casting (TCC-EZ) Versus Standard Wound Care and TCC-EZ in Treating Diabetic Foot Ulcers Best practice is to treat DFUs with standardized care and, if unsuccessful, use advanced modalities. This prospective clinical trial will compare healing rates between two treatment modalities in patients with DFUs in an ambulatory wound care clinic. The treatments are Total Contact Cast (TCC-EZ) with AmnioExcel® and TCC-EZ with standard treatment.
Adult participants 18 years or older with a diabetic foot ulcer located on the plantar surface and >1 cm in diameter will be asked by the Altru Wound Care Clinic MD or Family Nurse Practitioner visit to participate in the study if they have not demonstrated a 50% in reduction in wound area after two weeks of standard treatment. For those potential subjects who do not have 3rd party reimbursement the cost of the product and application will be covered by the respective company. They must be cognitively intact as evaluated by wound clinic primary care providers. Participants must agree to use the study treatments as directed, and to keep clinic visits during the 12-week trial or until the ulcer closes, whichever comes first.
Read the detailed description
A TCC offloads pressure and is the gold standard for DFU treatment, as documented in several studies. The TCC results in an average healing rate of 80-90% within 6 weeks, yet only about 6% of DFU patients receive the TCC. The TCC requires special provider training for application. Given the high efficacy and low complication risk for the TCC, clinicians need to use the TCC to treat DFUs. Literature supports use of the TCC combined with other wound bed treatment modalities. AmnioExCel® is a dehydrated, extracellular human amnion derived tissue allograft that provides a structural tissue matrix that promotes angiogenesis, collagen matrix formation and re-epithelization (Werber et al., 2013). This study will look at whether or not combining AmnioExCel® and a TCC-EZ results in a better healing rate than TCC-EZ and standard wound care.
Purpose/Research Questions:
The purpose of this prospective clinical trial is to compare healing rates between two treatment modalities in patients with DFUs in an ambulatory wound care clinic. The treatments are Total Contact Casting (TCC-EZ) with AmnioExCel® and TCC-EZ with standard treatment.
Research Questions:
- What is the difference in reduction in wound bed area for diabetic foot ulcers (DFUs) treated with Total Contact Casting TCC-EZ and AmnioExCel® compared to those treated with TCC-EZ and standard wound treatment?
- What is the difference in time to closure for DFUs treated with TCC-EZ and AmnioExCel® compared to those treated with TCC-EZ and standard wound treatment?
- What is the difference in cost of treatment for a diabetic foot ulcer treated with TCC-EZ and AmnioExCel® as compared to TCC-EZ with standard wound treatment?
- What is the relationship between the hemoglobin A1c test(HbA1c) or glycated hemoglobin test and reduction in wound bed area for DFUs treated with TCC-EZ and AmnioExCel® compared to those treated with TCC-EZ and standard wound treatment?
- What is the relationship between HbA1c and time to closure for DFUs with TCC-EZ and AmnioExCel® compared to those treated with TCC-EZ and standard wound treatment?
- What is the subjects' reported satisfaction using TCC-EZ?
- What is the reoccurrence of DFUs in a 90 day post treatment follow up?
- What are the characteristics of adverse side effects using TCC-EZ and AmnioExCel®?
Methods:
All patients in this study will receive 2 weeks of usual wound care consisting of wound cleansing, removal of pressure (offloading), sharp debridement as needed, and maintenance of a moist wound environment. If they have demonstrated less than a 50% improvement in reduction in wound area of their DFU over 2 weeks, subjects will be approached for participation in this study. If they agree to participate, they will be randomly assigned to one of the two treatment groups. Treatment for Group A will consist of TCC-EZ® and AmnioExCel® and treatment for Group B will consist of standard wound care and TCC-EZ® and standard wound care. If the subject has more than one ulcer the largest ulcer will be used for inclusion in the study. At the beginning and end of the study blood samples for HbA1c will be taken and if the HbA1c is greater than 15%, subjects will be excluded or if random blood sugar is greater than 450 mg/dl (Marston et al., 2003). Study participation will be for 12 weeks or less if the wound closes before 12 weeks. DFUs not closed at the end of the 12 weeks of the study will continue to be treated until closed based on the decision of the Altru Wound Care Clinic providers. Complete wound closure will be defined as 100% re-epithelization without drainage or infection. Subjects clinic charts/records will be reviewed by the researchers to collect the following data: group assigned to, gender, age, diabetes diagnosis, co-morbidities, time ulcer has been present, if conventional treatment occurred for two weeks, date of 1st wound clinic visit, last HbA1c, date ulcer 1st noticed by patient, depth, and size of ulcer, ankle-brachial index, and ulcer characteristics at each visit will also be documented. At the conclusion of the study, subjects will complete a 12 question satisfaction questionnaire and six demographic questions on the TCC-EZ which will be administered by the clinic nurse or provider. Subjects may elect to withdraw from the study at any time without repercussion.
- Conditions
- Diabetic Foot Ulcers, Diabetes
- Being tested
- Topical wound dressing, Human Amnion Allograft, usual wound care
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical wound dressingDevice
Topical Wound Dressing
Human Amnion AllograftBiological
Also called AmnioExCel
Change dressing every two to three weeks and TCC-EZ is changed weekly for 12 or until healed.
usual wound careOther
assessment, wound cleansing, debridement, moist wound environment, and off-loading
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | TCC-EZ and Standard Wound Care (Topical wound dressing) Two dressing and cast changes in week one followed by weekly applications until 12 weeks or closure which ever occurs first. Usual wound care would involve assessment, debridement, moist wound environment, and off-loading. Receives: Device: Topical wound dressing; Other: usual wound care |
| Intervention | Experimental | TCC-EZ and Human Amnion Allograft One dressing and two cast changes in week one followed by dressing change every two to three weeks and weekly cast changes until 12 weeks or closure which ever occurs first. Usual wound care would involve assessment, debridement, moist wound environment, and off-loading. Receives: Biological: Human Amnion Allograft; Other: usual wound care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to closure of a Diabetic Foot Ulcer using Human Amnion Allograft and Total Contact Casting vs Standard Wound Care and Total Contact Casting.
Number of days to closure of the DFUs.
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 posted22 Jan 2015 (estimated)
- Study startAug 2014
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (estimated)
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Dakota
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Thompson, University of North Dakota
- Investigators
- Patricia A Thompson, MS,RN, Principal investigator, University of North Dakota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344329
- Sponsor's protocol ID
- TCC-104
- Acronym
- TAD
- Status last verified
- May 2017
- First submitted
- 16 Jan 2015
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Total Contact Casting (TCC-EZ) Using Human Amnion Allograft (AmnioExcel) Versus Total Contact Casting (TCC-EZ) and Standard Wound Care in Treating Diabetic Foot Ulcers (TAD)
- ClinicalTrials.gov ID
- NCT02344329
- Acronym / sponsor ID
- TAD / TCC-104
- Conditions
- Diabetic Foot Ulcers, Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of North DakotaUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 22 Jan 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.
A Comparison of AmnioExcel® and Total Contact Casting (TCC-EZ) Versus Standard Wound Care and TCC-EZ in Treating Diabetic Foot Ulcers Best practice is to treat DFUs with standardized care and, if unsuccessful, use advanced modalities. This prospective clinical trial will compare healing rates between two treatment modalities in patients with DFUs in an ambulatory wound care clinic. The treatments are Total Contact Cast (TCC-EZ) with AmnioExcel® and TCC-EZ with standard treatment.
Adult participants 18 years or older with a diabetic foot ulcer located on the plantar surface and >1 cm in diameter will be asked by the Altru Wound Care Clinic MD or Family Nurse Practitioner visit to participate in the study if they have not demonstrated a 50% in reduction in wound area after two weeks of standard treatment. For those potential subjects who do not have 3rd party reimbursement the cost of the product and application will be covered by the respective company. They must be cognitively intact as evaluated by wound clinic primary care providers. Participants must agree to use the study treatments as directed, and to keep clinic visits during the 12-week trial or until the ulcer closes, whichever comes first.
Detailed description
A TCC offloads pressure and is the gold standard for DFU treatment, as documented in several studies. The TCC results in an average healing rate of 80-90% within 6 weeks, yet only about 6% of DFU patients receive the TCC. The TCC requires special provider training for application. Given the high efficacy and low complication risk for the TCC, clinicians need to use the TCC to treat DFUs. Literature supports use of the TCC combined with other wound bed treatment modalities. AmnioExCel® is a dehydrated, extracellular human amnion derived tissue allograft that provides a structural tissue matrix that promotes angiogenesis, collagen matrix formation and re-epithelization (Werber et al., 2013). This study will look at whether or not combining AmnioExCel® and a TCC-EZ results in a better healing rate than TCC-EZ and standard wound care.
Purpose/Research Questions:
The purpose of this prospective clinical trial is to compare healing rates between two treatment modalities in patients with DFUs in an ambulatory wound care clinic. The treatments are Total Contact Casting (TCC-EZ) with AmnioExCel® and TCC-EZ with standard treatment.
Research Questions:
- What is the difference in reduction in wound bed area for diabetic foot ulcers (DFUs) treated with Total Contact Casting TCC-EZ and AmnioExCel® compared to those treated with TCC-EZ and standard wound treatment?
- What is the difference in time to closure for DFUs treated with TCC-EZ and AmnioExCel® compared to those treated with TCC-EZ and standard wound treatment?
- What is the difference in cost of treatment for a diabetic foot ulcer treated with TCC-EZ and AmnioExCel® as compared to TCC-EZ with standard wound treatment?
- What is the relationship between the hemoglobin A1c test(HbA1c) or glycated hemoglobin test and reduction in wound bed area for DFUs treated with TCC-EZ and AmnioExCel® compared to those treated with TCC-EZ and standard wound treatment?
- What is the relationship between HbA1c and time to closure for DFUs with TCC-EZ and AmnioExCel® compared to those treated with TCC-EZ and standard wound treatment?
- What is the subjects' reported satisfaction using TCC-EZ?
- What is the reoccurrence of DFUs in a 90 day post treatment follow up?
- What are the characteristics of adverse side effects using TCC-EZ and AmnioExCel®?
Methods:
All patients in this study will receive 2 weeks of usual wound care consisting of wound cleansing, removal of pressure (offloading), sharp debridement as needed, and maintenance of a moist wound environment. If they have demonstrated less than a 50% improvement in reduction in wound area of their DFU over 2 weeks, subjects will be approached for participation in this study. If they agree to participate, they will be randomly assigned to one of the two treatment groups. Treatment for Group A will consist of TCC-EZ® and AmnioExCel® and treatment for Group B will consist of standard wound care and TCC-EZ® and standard wound care. If the subject has more than one ulcer the largest ulcer will be used for inclusion in the study. At the beginning and end of the study blood samples for HbA1c will be taken and if the HbA1c is greater than 15%, subjects will be excluded or if random blood sugar is greater than 450 mg/dl (Marston et al., 2003). Study participation will be for 12 weeks or less if the wound closes before 12 weeks. DFUs not closed at the end of the 12 weeks of the study will continue to be treated until closed based on the decision of the Altru Wound Care Clinic providers. Complete wound closure will be defined as 100% re-epithelization without drainage or infection. Subjects clinic charts/records will be reviewed by the researchers to collect the following data: group assigned to, gender, age, diabetes diagnosis, co-morbidities, time ulcer has been present, if conventional treatment occurred for two weeks, date of 1st wound clinic visit, last HbA1c, date ulcer 1st noticed by patient, depth, and size of ulcer, ankle-brachial index, and ulcer characteristics at each visit will also be documented. At the conclusion of the study, subjects will complete a 12 question satisfaction questionnaire and six demographic questions on the TCC-EZ which will be administered by the clinic nurse or provider. Subjects may elect to withdraw from the study at any time without repercussion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: Topical wound dressing, Other: usual wound careTCC-EZ and Standard Wound Care (Topical wound dressing) Two dressing and cast changes in week one followed by weekly applications until 12 weeks or closure which ever occurs first. Usual wound care would involve assessment, debridement, moist wound environment, and off-loading. |
| Intervention | Experimental | Biological: Human Amnion Allograft, Other: usual wound careTCC-EZ and Human Amnion Allograft One dressing and two cast changes in week one followed by dressing change every two to three weeks and weekly cast changes until 12 weeks or closure which ever occurs first. Usual wound care would involve assessment, debridement, moist wound environment, and off-loading. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects will be included if they are 18 years of age or older
- have a diagnosis of diabetes type 1 or 2
- random blood sugar of 450 or < and HbA1c of 15% or < drawn quarterly prior to study
- the ulcer has been present for a minimum of 2 weeks under the current investigators care
- the foot ulcer is on the plantar surface of the forefoot or heel and > 0.5cm2 in size at day 0
Key exclusion criteria (9 listed)
- Subjects younger that 18 years of age
- no current diagnosis of diabetes type 1 or 2
- has uncontrolled hyperglycemia random blood sugar of > 450 mg/dl
- HbA1c > 15%
- gangrene present on any part of the affected foot
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 |
|---|---|---|
| Topical wound dressingTopical Wound Dressing | Device | Control |
| Human Amnion AllograftAlso: AmnioExCelChange dressing every two to three weeks and TCC-EZ is changed weekly for 12 or until healed. | Biological | Intervention |
| usual wound careassessment, wound cleansing, debridement, moist wound environment, and off-loading | Other | Control, Intervention |
Primary outcome
Time to closure of a Diabetic Foot Ulcer using Human Amnion Allograft and Total Contact Casting vs Standard Wound Care and Total Contact Casting.
Time frame: 12 weeks
Number of days to closure of the DFUs.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
Patricia A Thompson, MS,RN principal investigator
University of North Dakota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topical wound dressing, Human Amnion Allograft and usual wound care in people with Diabetic Foot Ulcers and Diabetes, run by University of North Dakota at 1 site 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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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 closure of a Diabetic Foot Ulcer using Human Amnion Allograft and Total Contact Casting vs Standard Wound Care and Total Contact Casting. (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 9 May 2017.