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

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ClinicalTrials.gov Identifier: NCT01450943
Recruitment Status : Completed
First Posted : October 13, 2011
Results First Posted : September 17, 2019
Last Update Posted : September 17, 2019
Sponsor:
Collaborator:
VA Northern California Health Care System
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetic Foot Ulcer
Interventions Device: SECONDARY dressing gauze and tape
Procedure: debridement, irrigation
Device: Dermagraft
Device: Oasis
Enrollment 120
Recruitment Details 120 subjects enrolled from which 2 study subjects were not randomized into any groups and were terminated from the study; therefore, we only had overall of 118 study subjects.
Pre-assignment Details  
Arm/Group Title Standard of Care Dermagraft Oasis
Hide Arm/Group Description Consist of subjects who were randomized to treatment with standard of Care (SOC) which included debridement, irritation, primary dressing, Adaptic, secondary dressing gauze and tape.

These are study subject who were randomized to treatment arm with Dermagraft. Dermagraft is a cryopreserved human fibroblast-derived dermal substitute composed of viable newborn foreskin fibroblasts, seeded onto a bio-absorbable polyglactin mesh.

The treatment included debridement, irrigation, primary dressing and Dermagraft and Adaptic, and secondary dressing with gauze and tape.

Dermagraft placed per company protocol

These are study subject who were randomized to treatment arm with Oasis. Oasis is a bio-absorbable ECM derived from porcine small intestinal submucosa. the product is processed using proprietary methods to retain its original structure while stored at room temperature.

The treatment included debridement, irrigation, primary dressing and Oasis and Adaptic, and secondary dressing with gauze and tape.

Oasis placed per company protocol

Period Title: Overall Study
Started 28 42 48
Completed 26 35 42
Not Completed 2 7 6
Reason Not Completed
Screen failure, loss to follow-up             2             7             6
Arm/Group Title Standard of Care Dermagraft Oasis Total
Hide Arm/Group Description Consist of subjects who were randomized to treatment with standard of Care (SOC) which included debridement, irritation, primary dressing, Adaptic, secondary dressing gauze and tape.

Study subjects who were randomized to treatment arm with Dermagraft. Dermagraft is a cryopreserved human fibroblast-derived dermal substitute composed of viable newborn foreskin fibroblasts, seeded onto a bio-absorbable polyglactin mesh.

The treatment included debridement, irrigation, primary dressing and Dermagraft and Adaptic, and secondary dressing with gauze and tape.

Dermagraft placed per company protocol

Study subjects who were randomized to treatment arm with Oasis. Oasis is a bio-absorbable ECM derived from porcine small intestinal submucosa. the product is processed using proprietary methods to retain its original structure while stored at room temperature.

The treatment included debridement, irrigation, primary dressing and Oasis and Adaptic, and secondary dressing with gauze and tape.

Oasis placed per company protocol

Total of all reporting groups
Overall Number of Baseline Participants 28 42 48 118
Hide Baseline Analysis Population Description
Veteran subject patient population
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 42 participants 48 participants 118 participants
63.31  (9.09) 62.83  (9.3) 61.88  (8.64) 62.67  (9.01)
Sex: Female, Male   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Analyzed participants Number Analyzed 28 participants 42 participants 48 participants 118 participants
Female
2
   7.1%
0
   0.0%
1
   2.1%
3
   2.5%
Male
26
  92.9%
42
 100.0%
47
  97.9%
115
  97.5%
[1]
Measure Description: Study subjects information was directly obtained from the individuals and/or patient medical records
[2]
Measure Analysis Population Description: Northern California veteran patient population
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Analyzed participants Number Analyzed 28 participants 42 participants 48 participants 118 participants
Hispanic or Latino
0
   0.0%
3
   7.1%
4
   8.3%
7
   5.9%
Not Hispanic or Latino
28
 100.0%
39
  92.9%
44
  91.7%
111
  94.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Analyzed participants Number Analyzed 28 participants 42 participants 48 participants 118 participants
American Indian or Alaska Native
2
   7.1%
0
   0.0%
6
  12.5%
8
   6.8%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   7.1%
1
   2.4%
6
  12.5%
9
   7.6%
White
21
  75.0%
37
  88.1%
33
  68.8%
91
  77.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
  10.7%
4
   9.5%
3
   6.3%
10
   8.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 28 participants 42 participants 48 participants 118 participants
28
 100.0%
42
 100.0%
48
 100.0%
118
 100.0%
BMI  
Median (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 28 participants 42 participants 48 participants 118 participants
36.52  (6.59) 32.44  (5.32) 36.51  (11.55) 35.15  (7.83)
1.Primary Outcome
Title Wound Closure by Week 15
Hide Description The primary outcome of interest is defined as the wound healed completely on or before visit 15, regardless of a later recurrence.
Time Frame 15 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Outcome results consist of data available for the Northern California Veteran patient population participants who completed the study.
Arm/Group Title Standard of Care Dermagraft Oasis
Hide Arm/Group Description:
Consist of subjects who were randomized to treatment with standard of Care (SOC) which included debridement, irritation, primary dressing, Adaptic, secondary dressing gauze and tape without any grafts.

Study subjects who were randomized to treatment arm with Dermagraft. Dermagraft is a cryopreserved human fibroblast-derived dermal substitute composed of viable newborn foreskin fibroblasts, seeded onto a bio-absorbable polyglactin mesh.

The treatment included debridement, irrigation, primary dressing and Dermagraft and Adaptic, and secondary dressing with gauze and tape.

Dermagraft placed per company protocol

Study subjects who were randomized to treatment arm with Oasis. Oasis is a bio-absorbable ECM derived from porcine small intestinal submucosa. the product is processed using proprietary methods to retain its original structure while stored at room temperature.

The treatment included debridement, irrigation, primary dressing and Oasis and Adaptic, and secondary dressing with gauze and tape.

Oasis placed per company protocol

Overall Number of Participants Analyzed 26 35 42
Measure Type: Count of Participants
Unit of Measure: Participants
Not Healed
10
  38.5%
15
  42.9%
9
  21.4%
Healed completely
16
  61.5%
20
  57.1%
33
  78.6%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dermagraft, Oasis
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0517
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 2.712595
Confidence Interval (2-Sided) 95%
0.9141 to 8.4839
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Wound Closure at 20 Weeks
Hide Description 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.
Time Frame 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Primary Outcome results consist of data still available for the Veteran patient population participants who completed the study.
Arm/Group Title Standard of Care Dermagraft Oasis
Hide Arm/Group Description:
Consist of subjects who were randomized to treatment with standard of Care (SOC) which included debridement, irritation, primary dressing, Adaptic, secondary dressing gauze and tape.

Study subjects who were randomized to treatment arm with Dermagraft. Dermagraft is a cryopreserved human fibroblast-derived dermal substitute composed of viable newborn foreskin fibroblasts, seeded onto a bio-absorbable polyglactin mesh.

The treatment included debridement, irrigation, primary dressing and Dermagraft and Adaptic, and secondary dressing with gauze and tape.

Dermagraft placed per company protocol

Study subjects who were randomized to treatment arm with Oasis. Oasis is a bio-absorbable ECM derived from porcine small intestinal submucosa. the product is processed using proprietary methods to retain its original structure while stored at room temperature.

The treatment included debridement, irrigation, primary dressing and Oasis and Adaptic, and secondary dressing with gauze and tape.

Oasis placed per company protocol

Overall Number of Participants Analyzed 23 34 39
Measure Type: Number
Unit of Measure: Wound Closure in weeks
Not healed 5 9 12
Healed completely 18 25 27
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Dermagraft, Oasis
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7974
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.812339
Confidence Interval (2-Sided) 95%
0.2543 to 2.5224
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Cost Effectiveness
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Data not available because the investigators did not asses the cost effectiveness for the study.
Arm/Group Title Standard of Care Dermagraft Oasis
Hide Arm/Group Description:

SOC Group:

debridement, irrigation , PRIMARY dressing and Adaptic, SECONDARY dressing gauze and tape

SECONDARY dressing gauze and tape: SECONDARY dressing gauze and tape

debridement, irrigation: debridement, irrigation

Dermagraft Group: debridement, irrigation , PRIMARY dressing Dermagraft and Adaptic, SECONDARY dressing gauze and tape

SECONDARY dressing gauze and tape: SECONDARY dressing gauze and tape

debridement, irrigation: debridement, irrigation

Dermagraft: Dermagraft per company protocol

Oasis Group:

debridement, irrigation , PRIMARY dressing Oasis and Adaptic, SECONDARY dressing gauze and tape

SECONDARY dressing gauze and tape: SECONDARY dressing gauze and tape

debridement, irrigation: debridement, irrigation

Oasis: Oasis per company protocol

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
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.
Adverse Event Reporting Description Adverse events were collected through the patient and/or through patient chart review.
 
Arm/Group Title Standard of Care Dermagraft Oasis
Hide Arm/Group Description Consist of subjects who were randomized to treatment with standard of Care (SOC) which included debridement, irritation, primary dressing, Adaptic, secondary dressing gauze and tape.

Study subjects who were randomized to treatment arm with Dermagraft. Dermagraft is a cryopreserved human fibroblast-derived dermal substitute composed of viable newborn foreskin fibroblasts, seeded onto a bio-absorbable polyglactin mesh.

The treatment included debridement, irrigation, primary dressing and Dermagraft and Adaptic, and secondary dressing with gauze and tape.

Dermagraft placed per company protocol

Study subjects who were randomized to treatment arm with Oasis. Oasis is a bio-absorbable ECM derived from porcine small intestinal submucosa. the product is processed using proprietary methods to retain its original structure while stored at room temperature.

The treatment included debridement, irrigation, primary dressing and Oasis and Adaptic, and secondary dressing with gauze and tape.

Oasis placed per company protocol

All-Cause Mortality
Standard of Care Dermagraft Oasis
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/28 (17.86%)      6/42 (14.29%)      10/48 (20.83%)    
Show Serious Adverse Events Hide Serious Adverse Events
Standard of Care Dermagraft Oasis
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/28 (21.43%)      15/42 (35.71%)      16/48 (33.33%)    
Infections and infestations       
Non-study related  [1]  6/28 (21.43%)  6 13/42 (30.95%)  13 16/48 (33.33%)  16
Involved study related foot ulcer  [2]  0/28 (0.00%)  0 2/42 (4.76%)  2 0/48 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Cardiac, acute cholecystitis, suicide ideation
[2]
Infection that require in patient IV treatment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard of Care Dermagraft Oasis
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/28 (10.71%)      4/42 (9.52%)      2/48 (4.17%)    
Cardiac disorders       
Non-study related * [1]  3/28 (10.71%)  3 4/42 (9.52%)  4 2/48 (4.17%)  2
*
Indicates events were collected by non-systematic assessment
[1]
Cardiac, Acute cholecystitis, infections
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sara Dahle, D.P.M., M.P.H.
Organization: VA Northern California Health Care System
Phone: 916-843-7151
EMail: Sara.dahle@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01450943     History of Changes
Other Study ID Numbers: SURG-005-10S
11-04-00618 ( Other Grant/Funding Number: VA Northern California Health Care System )
First Submitted: October 7, 2011
First Posted: October 13, 2011
Results First Submitted: July 31, 2019
Results First Posted: September 17, 2019
Last Update Posted: September 17, 2019