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

Participant Flow

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
Arm/Group Description	Consist of subjects who were random...	These are study subject who were ra...	These are study subject who were ra...
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

Baseline Characteristics

Arm/Group Title		Standard of Care	Dermagraft	Oasis	Total
Arm/Group Description		Consist of subjects who were random...	Study subjects who were randomized ...	Study subjects who were randomized ...	Total of all reporting groups
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
Baseline Analysis Population Description		...
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
United States		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)

Outcome Measures

1.Primary Outcome


Title	Wound Closure by Week 15
Description	The primary outcome of interest is defined as the wound healed complet...
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

Outcome Measure Data

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
Arm/Group Description:	Consist of subjects who were random...	Study subjects who were randomized ...	Study subjects who were randomized ...
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%

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
Description	Complete wound closure at study endpoint. The Secondary outcome of int...
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

Outcome Measure Data

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
Arm/Group Description:	Consist of subjects who were random...	Study subjects who were randomized ...	Study subjects who were randomized ...
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

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
Description	[Not Specified]
Description	[Not Specified]
Time Frame	12 weeks

Outcome Measure Data

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
Arm/Group Description:	SOC Group: ...	Dermagraft Group: debridement, irri...	Oasis Group: ...
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.

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.
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
Arm/Group Description	Consist of subjects who were random...		Study subjects who were randomized ...		Study subjects who were randomized ...
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%)
Serious Adverse Events 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
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

Limitations and Caveats

[Not Specified]

More Information

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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

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