Diabetic Foot UlcerPhase 3DOLCENCT01450943

VA MERIT: A Comparative Efficacy Study: Treatment of Non-Healing Diabetic

A Phase 3 study testing SECONDARY dressing gauze and tape, debridement, irrigation and Dermagraft in people with Diabetic Foot Ulcer, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of this study is to assess the effectiveness of cellular dermal replacement tissue vs. non-viable extracellular matrix (ECM) for the treatment of non-healing diabetic foot ulcers. Our hypothesis is that these devices are of equal efficacy. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Diabetic Foot Ulcer
What is being tested?: SECONDARY dressing gauze and tape, debridement, irrigation and Dermagraft
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteUnited States
Study dates: 1 Oct 2011to 4 Apr 2018
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

(Answering NO will exclude patient):
An Institutional Review Board (IRB) Informed Consent Form signed and dated prior to any study-related activities.
The area of the study ulcer after debridement is between 1 cm2 and 25 cm2 at Visit 3/Week 0.
Subjects between 18 and 85 years of age.
Subject's highest Ankle-Brachial Pressure Index (ABPI) / Ankle-Arm Index (AAI) is greater than or equal to 0.80 and lower than 1.4 (the highest ABPI/AAI value from three measurements within last 6 months shall apply).or a toe-arm index is equal to or higher than 0.6.
The patient has one or more diabetic ulcers on the target foot with only one ulcer selected as the study (target) ulcer. The target ulcer must be at least 4 cm from a non-target ulcer and in the Investigator's opinion, be unlikely to coalesce with another ulcer within 12 weeks of randomization.

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Subject's study ulcer is full thickness and does not extend to bone, muscle, or tendon.
Subject's study ulcer has been present at least 4 weeks prior to the initial screening (Visit 1) or 6 weeks at randomization (Visit 3).
Subject has been diagnosed with Type 1 or Type 2 diabetes and HbA1c is less than 10%.
Study ulcer has no clinical feature of infection (2 signs of inflammation and elevated bacterial load of the wound).
For female subjects of childbearing age potential, the subject has a negative pregnancy test and is not lactating for the duration of the study.
Subject understands the requirements of this study and is willing to comply with all the study requirements.

Who cannot join

(Answering YES will exclude patient):
The subject is diagnosed with cancer and is undergoing treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before enrollment.
The subject is diagnosed with HIV/AIDS.
The subject is diagnosed with any bleeding disorders.
The subject is diagnosed with any connective tissue diseases.
For female subjects, the subject is pregnant or lactating.

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The subject has a history of illicit drug use within one year of enrollment.
In the past year, the subject experiences episodes of drinking more than 5 alcoholic beverages in less than two hours and/or drinking alcohol has become a problem in interpersonal relationships, work, driving and/or their behavior in general.
The subject has any active infected wounds or osteomyelitis (confirmed by bone biopsy, MRI or bone scan).
Doppler exam within the last 365 days demonstrating reflux greater than 0.5 seconds.
The subject is diagnosed with active Charcot as described by Saunder's classification system.
The subject manifests signs of poor nutritional status and/or albumin level < 2.9.
The subject has been exposed to Dermagraft and/or Oasis in the last 60 days.
The study ulcer size is less than 0.5 cm2 or greater than 25 cm2.
The subject has any porcine allergy or cow product allergy.
The subject's recent (last 30 days) chemistry tests serum creatinine is 2 times above the upper limit of normal and/or LFT's 3 times above the upper limit of normal.
Between Visit 1/Week -2 and Visit 3/Week 0 (randomization) the study ulcer has decreased in size by more than 40%, or increased in size by more than 50%.

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Northern California Health Care System, Mather, CA
Sacramento, California, 95655

Other trials in United States

About this study

Official title: A Comparative Efficacy Study: Treatments of Non-Healing Diabetic Foot Ulcers

Conditions: Diabetic Foot Ulcer
Being tested: SECONDARY dressing gauze and tape, debridement, irrigation, Dermagraft, Oasis
Keywords: Diabetic Foot Ulcer, Chronic wounds, Chronic ulcers, Oasis, Dermagraft, Adaptic
Medical subject headings: Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SECONDARY dressing gauze and tapeDevice
SECONDARY dressing gauze and tape
debridement, irrigationProcedure or surgery
debridement, irrigation
DermagraftDevice
Dermagraft per company protocol
OasisDevice
Oasis per company protocol

Study groups in NCT01450943
Study group	Role	What they receive
Standard of care	Active comparator	debridement, irrigation , PRIMARY dressing Adaptic and Iodosorb, SECONDARY dressing gauze and tape Receives: Device: SECONDARY dressing gauze and tape; Procedure: debridement, irrigation
Dermagraft	Experimental	debridement, irrigation , PRIMARY dressing Dermagraft and Adaptic, SECONDARY dressing gauze and tape Receives: Device: SECONDARY dressing gauze and tape; Procedure: debridement, irrigation; Device: Dermagraft
Oasis	Experimental	debridement, irrigation , PRIMARY dressing Oasis and Adaptic, SECONDARY dressing gauze and tape Receives: Device: SECONDARY dressing gauze and tape; Procedure: debridement, irrigation; Device: Oasis

What is being measured

The primary outcome is the main question the study is designed to answer.

Wound Closure by Week 15
The primary outcome of interest is defined as the wound healed completely on or before visit 15, regardless of a later recurrence.
Measured: 15 weeks

Secondary outcomes (2)

Wound Closure at 20 Weeks
Complete wound closure at study endpoint. The Secondary outcome of interest is defined as the wound healed completely on or before visit 19, regardless of a later recurrence. The number of subjects analyzed at secondary outcome differs from primary outcome due to some subjects not completing the study.
Measured: 20 weeks
Cost Effectiveness
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20114 Apr 2018

First posted13 Oct 2011 (estimated)
Study start1 Oct 2011
Primary completion14 Dec 2017
Study completion4 Apr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01450943
Sponsor's protocol ID: SURG-005-10S
Other IDs: 11-04-00618
Acronym: DOLCE
Status last verified: Aug 2019
First submitted: 7 Oct 2011
Last updated: 17 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Publications

Lev-Tov H, Li CS, Dahle S, Isseroff RR. Cellular versus acellular matrix devices in treatment of diabetic foot ulcers: study protocol for a comparative efficacy randomized controlled trial. Trials. 2013 Jan 9;14:8. doi: 10.1186/1745-6215-14-8.
PubMed 23298410

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Diabetic Foot Ulcer trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparative Efficacy Study: Treatments of Non-Healing Diabetic Foot Ulcers
ClinicalTrials.gov ID: NCT01450943
Acronym / sponsor ID: DOLCE / SURG-005-10S
Conditions: Diabetic Foot Ulcer
Keywords: Diabetic Foot Ulcer, Chronic wounds, Chronic ulcers, Oasis, Dermagraft, Adaptic
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Collaborators: VA Northern California Health Care System
Study start: 1 Oct 2011 (actual)
Primary completion: 14 Dec 2017 (actual)
Study completion: 4 Apr 2018 (actual)
First posted: 13 Oct 2011 (estimated)
Results: Posted 17 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Standard of care	Active comparator	Device: SECONDARY dressing gauze and tape, Procedure: debridement, irrigationdebridement, irrigation , PRIMARY dressing Adaptic and Iodosorb, SECONDARY dressing gauze and tape
Dermagraft	Experimental	Device: SECONDARY dressing gauze and tape, Procedure: debridement, irrigation, Device: Dermagraftdebridement, irrigation , PRIMARY dressing Dermagraft and Adaptic, SECONDARY dressing gauze and tape
Oasis	Experimental	Device: SECONDARY dressing gauze and tape, Procedure: debridement, irrigation, Device: Oasisdebridement, irrigation , PRIMARY dressing Oasis and Adaptic, SECONDARY dressing gauze and tape

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

An Institutional Review Board (IRB) Informed Consent Form signed and dated prior to any study-related activities.
The area of the study ulcer after debridement is between 1 cm2 and 25 cm2 at Visit 3/Week 0.
Subjects between 18 and 85 years of age.
Subject's highest Ankle-Brachial Pressure Index (ABPI) / Ankle-Arm Index (AAI) is greater than or equal to 0.80 and lower than 1.4 (the highest ABPI/AAI value from three measurements within last 6 months shall apply).or a toe-arm index is equal to or higher than 0.6.
The patient has one or more diabetic ulcers on the target foot with only one ulcer selected as the study (target) ulcer. The target ulcer must be at least 4 cm from a non-target ulcer and in the Investigator's opinion, be unlikely to coalesce with another ulcer within 12 weeks of randomization.

Key exclusion criteria (17 listed)

The subject is diagnosed with cancer and is undergoing treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before enrollment.
The subject is diagnosed with HIV/AIDS.
The subject is diagnosed with any bleeding disorders.
The subject is diagnosed with any connective tissue diseases.
For female subjects, the subject is pregnant or lactating.

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
SECONDARY dressing gauze and tapeSECONDARY dressing gauze and tape	Device	Dermagraft, Oasis, Standard of care
debridement, irrigationdebridement, irrigation	Procedure or surgery	Dermagraft, Oasis, Standard of care
DermagraftDermagraft per company protocol	Device	Dermagraft
OasisOasis per company protocol	Device	Oasis

Primary outcome

Wound Closure by Week 15
Time frame: 15 weeks
The primary outcome of interest is defined as the wound healed completely on or before visit 15, regardless of a later recurrence.

2 secondary outcomes

Wound Closure at 20 Weeks
Time frame: 20 weeks
Cost Effectiveness
Time frame: 12 weeks

Results and safety

Results posted to the registry on 17 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard of Care	28	26
Dermagraft	42	35
Oasis	48	42

Primary outcome: Wound Closure by Week 15

Time frame: 15 weeks. Count of participants. Unit: Participants

Measure	Standard of Care n = 26	Dermagraft n = 35	Oasis n = 42
Not Healed	10	15	9
Healed completely	16	20	33

Dermagraft vs Oasis: Odds Ratio (OR): 2.712595 (95% CI 0.9141 to 8.4839), p = 0.0517, Fisher Exact

Population analysed: Primary Outcome results consist of data available for the Northern California Veteran patient population participants who completed the study.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Visits 1-2: consent and screen the subject. Obtain medical history, vitals, concomitant medications, and adverse events recorded. Visit 3: If after two weeks, the subject qualifies to continue, the subject is randomized into one of three groups. Visits 4-15: Subjects follow up weekly for study visit which includes wounds undressed, assessed, cleaned and debrided, traced, photographed, and redressed again. Visit 16-19: These are the follow-up visits. There will be 4 visits spread over 16 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard of Care	6 of 28 (21.4%)	3 of 28 (10.7%)	5 of 28
Dermagraft	15 of 42 (35.7%)	4 of 42 (9.5%)	6 of 42
Oasis	16 of 48 (33.3%)	2 of 48 (4.2%)	10 of 48

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23298410Lev-Tov H, Li CS, Dahle S, Isseroff RR. Cellular versus acellular matrix devices in treatment of diabetic foot ulcers: study protocol for a comparative efficacy randomized controlled trial. Trials. 2013 Jan 9;14:8. doi: 10.1186/1745-6215-14-8.
Individual participant dataSharing planned: Undecided

Related trials for Diabetic Foot Ulcer

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.

Rivkah R. Isseroff, MD principal investigator

VA Northern California Health Care System, Mather, CA

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 12 inclusion and 17 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 17 Sep 2019. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Wound Closure by Week 15 (time frame: 15 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01450943, which also lists 1 linked publication.

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 17 Sep 2019.