A Safety and Efficacy Study of INTEGRA® Dermal Regenerati... | NCT01060670

Label	Type	Description	Intervention Names
Dermal Replacement Device	Experimental	Device: INTEGRA® Dermal Regeneration Template	Device: Integra® Dermal Regeneration Template
Moist Wound Therapy	Active Comparator	0.9% Saline gel	Other: Conventional Wound Therapy

Name	Type	Description	Arm Group Labels	Other Names
Integra® Dermal Regeneration Template	Device	Application of Integra® Dermal Regeneration Template in diabetic foot ulcer	Dermal Replacement Device

Measure	Description	Time Frame
Incidence of Complete Wound Closure	100% closure as assessed by the Investigator and confirmed at 2 consecutive treatment phase visits.	16 weeks

Measure	Description	Time Frame
Incidence of Complete Wound Closure	Percentage of subjects with complete wound closure of the study ulcer, as assessed by computerized planimetry, during the treatment phase.	16 weeks
Time to Complete Wound Closure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Type I or Type II diabetes mellitus
Glycosylated hemoglobin, HbA1c, ≤ 12%
Negative serum pregnancy test at screening for female participants of child-bearing potential
Willing and able to maintain the required off-loading (as applicable for the location for the ulcer) and applicable dressing changes
At least one DFU that met the following criteria:
1. Ulcer was diagnosed as a full-thickness neuropathic DFU that was located distal to the malleolus (excluding ulcers between the toes but including those of the heel),
2. Minimum 2-cm margin between the qualifying study ulcer and any other ulcers on the specified foot (post debridement),
3. Area greater than or equal to 1 square centimeter and less than or equal to 12 square centimeters (post debridement at the time of randomization),
4. Wagner grade 1 or 2,
5. Depth less than or equal to 5 millimeters with no exposed capsule, tendon or bone and no tunneling, undermining or sinus tracts,
6. Duration of the study ulcer was at least 30 days at the time of the screening visit
Adequate vascular perfusion of the affected limb

Exclusion Criteria:

Suspected or confirmed signs/symptoms of gangrene or wound infection on any part of the limb
History of hypersensitivity to bovine collagen and/or chondroitin.
Pregnancy
Previous treatment under this clinical protocol
Participation in another clinical trial involving a device or systematically administered investigational study drug or treatment within 30 days of the randomization visit.
Receiving or scheduled to receive a medication or treatment which, in the opinion of the investigator, was known to interfere with, or affect the rate and quality of wound healing
Any unstable condition or circumstance that could interfere with treatment regimen compliance
Excessive lymphedema that could interfere with wound healing
Unstable Charcot foot or Charcot with boney prominence
Ulcers secondary to a disease other than diabetes
Osteomyelitis with necrotic soft bone
Chopart amputation
History of bone cancer or metastatic disease of the affected limb, radiation therapy to the foot, or chemotherapy within the 12 months prior to randomization
Treatment with wound dressings that include growth factors, engineered tissues, or skin substitutes within 30 days of randomization or scheduled to receive such treatment during the study
Non-study ulcer requiring treatment that could not be treated during the study with moist wound therapy
History of or intercurrent illnesses or conditions (other than diabetes) that would compromise the safety of the subject, or the normal wound healing process
Employees or relatives of any member of the investigational site or sponsor
Size of the study ulcer following debridement decreased by more than 30% during the run in period

Facility	Status	City	State	ZIP	Country	Contacts
Costal Clinical Research		Mobile	Alabama	36608	United States
Stockdale Podiatry Group

ID	Title	Description
FG000	Active Treatment	INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
FG001	Control Treatment

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Incidence of Complete Wound Closure

100% closure as assessed by the Investigator and confirmed at 2 consecutive treatment phase visits.

The results were based on the Investigator assessment and ITT population.

Posted

Number

participants

16 weeks

ID	Title	Description
OG000	Active Treatment	INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
OG001	Control Treatment	Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.

Units	Counts
Participants	OG000154 OG001153

Title

Denominators

Categories

Title	Measurements
	OG00079 OG00149

Secondary

Incidence of Complete Wound Closure

Percentage of subjects with complete wound closure of the study ulcer, as assessed by computerized planimetry, during the treatment phase.

ITT Population

Posted

Number

percentage of subjects

16 weeks

ID	Title	Description
OG000	Active Treatment	INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
OG001	Control Treatment	Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.

Units	Counts
Participants	OG000

Secondary

Time to Complete Wound Closure

Measures the time to complete wound closure as assessed by the Investigator.

ITT Population complete wound healed with analyzable data

Posted

Mean

Standard Deviation

days

16 weeks

ID	Title	Description
OG000	Active Treatment	INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
OG001	Control Treatment	Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.

Units	Counts
Participants	OG000

Secondary

Time to Complete Wound Closure

Time to complete wound closure, as assessed by computerized planimetry.

ITT population complete wound healed with analyzable data

Posted

Median

Full Range

days

16 weeks

ID	Title	Description
OG000	Dermal Replacement Device	INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
OG001	Moist Wound Therapy	Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.

Units	Counts
Participants	OG000

Secondary

Rate of Wound Closure

Rate of wound closure as assessed by computerized planimetry

ITT Population

Posted

Mean

Standard Deviation

percentage wound closure/week

16 weeks

ID	Title	Description
OG000	Active Treatment	INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
OG001	Control Treatment	Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.

Units	Counts
Participants	OG000

Secondary

Incidence of Ulcer Recurrence

Measures the incidence of ulcer recurrence at the site of the study ulcer during the follow up phase.

ITT Population complete wound healed

Posted

Number

participants

12 weeks

ID	Title	Description
OG000	Active Treatment	INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
OG001	Control Treatment	Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.

Units	Counts
Participants	OG000

Secondary

Change in Short Form Health Survey (SF-36) Quality of Life Metrics

Short Form Health Survey (SF-36)- Quality of Life Metrics. The SF-36 was utilized and the Physical Function and Bodily Pain subscales were norm-based, with a Mean = 50, SD = 10. Scores could theoretically range from 0 to 100, with higher scores indicating a better health status.

ITT Population

Posted

Mean

Standard Deviation

units on a scale

Baseline and 16 weeks

ID	Title	Description
OG000	Active Treatment	INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
OG001	Control Treatment	Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.

Units	Counts
Participants

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected154 at risk EG0011 events1 affected153 at risk
atrial fibrillation	Cardiac disorders	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected154 at risk EG0010 events0 affected153 at risk
atrial flutter	Cardiac disorders	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected154 at risk EG0011 events1 affected153 at risk
cardiac failure	Cardiac disorders	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected154 at risk EG0010 events0 affected153 at risk
cardiac failure congestive	Cardiac disorders	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected154 at risk EG0012 events2 affected153 at risk
cardiac tamponade	Cardiac disorders	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected154 at risk EG0010 events0 affected153 at risk
cardiogenic shock	Cardiac disorders	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected154 at risk EG0011 events1 affected153 at risk
coronary artery disease	Cardiac disorders	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected154 at risk EG0011 events1 affected153 at risk
dyspnoea	Cardiac disorders	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected154 at risk EG0011 events1 affected153 at risk
cataract	Eye disorders	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected154 at risk EG0011 events1 affected153 at risk
gastritis	Gastrointestinal disorders	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected154 at risk EG0011 events1 affected153 at risk
chest pain	General disorders	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected154 at risk EG0011 events1 affected153 at risk
condition aggravated	General disorders	MedDRA (14.0)	Non-systematic Assessment	EG0002 events2 affected154 at risk EG0016 events6 affected153 at risk
multi orgain failure	General disorders	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected154 at risk EG0011 events1 affected153 at risk
non cardiac chest pain	General disorders	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected154 at risk EG0010 events0 affected153 at risk
cholecystitis acute	Hepatobiliary disorders	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected154 at risk EG0010 events0 affected153 at risk
drug hypersensitivity	Immune system disorders	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected154 at risk EG0012 events2 affected153 at risk
abcess	Infections and infestations	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected154 at risk EG0010 events0 affected153 at risk
abcess limb	Infections and infestations	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected154 at risk EG0013 events3 affected153 at risk
arthritis bacterial	Infections and infestations	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected154 at risk EG0011 events1 affected153 at risk
arthritis infective	Infections and infestations	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected154 at risk EG0011 events1 affected153 at risk
bacteraemia	Infections and infestations	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected154 at risk EG0011 events1 affected153 at risk
cellulitis	Infections and infestations	MedDRA (14.0)	Non-systematic Assessment	EG0007 events7 affected154 at risk EG0017 events6 affected153 at risk
diabetic foot infection	Infections and infestations	MedDRA (14.0)	Non-systematic Assessment	EG0008 events8 affected154 at risk EG0017 events6 affected153 at risk
gangrene	Infections and infestations	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected154 at risk EG0013 events3 affected153 at risk
infected skin ulcer	Infections and infestations	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected154 at risk EG0010 events0 affected153 at risk
localised infection	Infections and infestations	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected154 at risk EG0011 events1 affected153 at risk
osteomyelitis	Infections and infestations	MedDRA (14.0)	Non-systematic Assessment	EG0008 events8 affected154 at risk EG00115 events15 affected153 at risk
perineal abcess	Infections and infestations	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected154 at risk EG0010 events0 affected153 at risk
pneumonia	Infections and infestations	MedDRA (14.0)	Non-systematic Assessment	EG0003 events3 affected154 at risk EG0013 events3 affected153 at risk
sepsis	Infections and infestations	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected154 at risk EG0011 events1 affected153 at risk
septic shock	Infections and infestations	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected154 at risk EG0011 events1 affected153 at risk
soft tissue infection	Infections and infestations	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected154 at risk EG0011 events1 affected153 at risk
staphylococcal osteomyelitis	Infections and infestations	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected154 at risk EG0011 events1 affected153 at risk
urinary tract infection	Infections and infestations	MedDRA (14.0)	Non-systematic Assessment	EG0003 events1 affected154 at risk EG0012 events2 affected153 at risk
ankle fracture	Injury, poisoning and procedural complications	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected154 at risk EG0010 events0 affected153 at risk
renal hematoma	Injury, poisoning and procedural complications	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected154 at risk EG0011 events1 affected153 at risk
diabetic foot	Metabolism and nutrition disorders	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected154 at risk EG0011 events1 affected153 at risk
diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected154 at risk EG0015 events3 affected153 at risk
hypoglycaemia	Metabolism and nutrition disorders	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected154 at risk EG0011 events1 affected153 at risk
obesity	Metabolism and nutrition disorders	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected154 at risk EG0010 events0 affected153 at risk
coccydynia	Musculoskeletal and connective tissue disorders	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected154 at risk EG0011 events1 affected153 at risk
laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected154 at risk EG0010 events0 affected153 at risk
convulsion	Nervous system disorders	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected154 at risk EG0011 events1 affected153 at risk
loss of consciousness	Nervous system disorders	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected154 at risk EG0011 events1 affected153 at risk
syncope	Nervous system disorders	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected154 at risk EG0011 events1 affected153 at risk
mental disorder	Psychiatric disorders	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected154 at risk EG0011 events1 affected153 at risk
renal failure	Renal and urinary disorders	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected154 at risk EG0010 events0 affected153 at risk
renal mass	Renal and urinary disorders	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected154 at risk EG0011 events1 affected153 at risk
asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected154 at risk EG0011 events1 affected153 at risk
pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected154 at risk EG0011 events1 affected153 at risk
skin erosion	Skin and subcutaneous tissue disorders	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected154 at risk EG0010 events0 affected153 at risk
arterial insufficiency	Vascular disorders	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected154 at risk EG0011 events1 affected153 at risk
deep vein thrombosis	Vascular disorders	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected154 at risk EG0011 events1 affected153 at risk
extremity necrosis	Vascular disorders	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected154 at risk EG0011 events1 affected153 at risk
orthostatic hypotension	Vascular disorders	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected154 at risk EG0011 events1 affected153 at risk
peripheral arterial occlusive disease	Vascular disorders	MedDRA (14.0)	Non-systematic Assessment	EG0001 events1 affected154 at risk EG0010 events0 affected153 at risk
peripheral vascular disorder	Vascular disorders	MedDRA (14.0)	Non-systematic Assessment	EG0000 events0 affected154 at risk EG0011 events1 affected153 at risk

ID	Title	Description
BG000	Active Treatment	INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing and a gauze wrap and, an offloading/protective device were to be used in conjunction with the IDRT.
BG001	Control Treatment	Control Treatment consisted of moist wound therapy and was comprised of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing and a gauze wrap and, an offloading/protective device
BG002	Total	Total of all reporting groups

ID	Term
D005534	Foot Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D007871	Leg Ulcer
D012883	Skin Ulcer

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Active Treatment	INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.			38	154	0	154
EG001	Control Treatment	Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.			55	153	0	153