Trial Outcomes & Findings for AMNIOEXCEL® Plus vs A Marketed Comparator vs SOC in the Management of Diabetic Foot Ulcers (NCT NCT03547635)
NCT ID: NCT03547635
Last Updated: 2020-07-20
Results Overview
Complete wound closure is defined as complete skin re-epithelialization that is without drainage or dressing requirements.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
116 participants
Primary outcome timeframe
Wound closure assessed up to week 12 and confirmed 2 weeks later; only participants with wound closure at or before Week 12 and who maintained closure in follow-up reported
Results posted on
2020-07-20
Participant Flow
Participant milestones
| Measure |
AMNIOEXCEL Plus Amniotic Membrane
AMNIOEXCEL Plus Amniotic Membrane: AMNIOEXCEL Plus is a human placental-based tissue consisting of dehydrated, tri-layer Placental (Amnion/Chorion/Amnion) Allograft Membrane (T-PAM) layers. T-PAM is a minimally manipulated placental membrane product made from tissues donated by pre-screened mothers during planned C-sections and is intended for use as a wound covering. This product is an allograft tissue intended for homologous use for the repair, reconstruction and replacement of skin at the direction of a physician. AMNIOEXCEL Plus contains Human Cellular and Tissue Based Products (HCT/P) as defined by US FDA 21 CFR Part 1271. All donor recoveries are performed by BioDlogics, LLC, and adhere to the regulations regarding HCT/P recovery and the screening and testing of the tissue donor as verified through supplier audits.
|
A Marketed Comparator
A Marketed Comparator: bi-layered skin substitute: the epidermal layer is formed by human keratinocytes and has a well-differentiated stratum corneum; the dermal layer is composed of human fibroblasts in a bovine Type I collagen lattice. It is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1-month duration and which have not adequately responded to conventional ulcer therapy. This product is also indicated for use with standard DFU care for the treatment of full-thickness neuropathic DFUs of greater than three weeks' duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.
|
Standard of Care
Standard of Care: • Coban™
* Conforming gauze
* Optifoam® non-adhesive dressing
* Cotton Gauze
* Normal saline (liquid or gel)
* Non-adhering dressings
* Steristrips
* An offloading boot (Pneumatic Short Leg Walker), as appropriate
|
|---|---|---|---|
|
Overall Study
STARTED
|
41
|
38
|
37
|
|
Overall Study
COMPLETED
|
33
|
31
|
29
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
8
|
Reasons for withdrawal
| Measure |
AMNIOEXCEL Plus Amniotic Membrane
AMNIOEXCEL Plus Amniotic Membrane: AMNIOEXCEL Plus is a human placental-based tissue consisting of dehydrated, tri-layer Placental (Amnion/Chorion/Amnion) Allograft Membrane (T-PAM) layers. T-PAM is a minimally manipulated placental membrane product made from tissues donated by pre-screened mothers during planned C-sections and is intended for use as a wound covering. This product is an allograft tissue intended for homologous use for the repair, reconstruction and replacement of skin at the direction of a physician. AMNIOEXCEL Plus contains Human Cellular and Tissue Based Products (HCT/P) as defined by US FDA 21 CFR Part 1271. All donor recoveries are performed by BioDlogics, LLC, and adhere to the regulations regarding HCT/P recovery and the screening and testing of the tissue donor as verified through supplier audits.
|
A Marketed Comparator
A Marketed Comparator: bi-layered skin substitute: the epidermal layer is formed by human keratinocytes and has a well-differentiated stratum corneum; the dermal layer is composed of human fibroblasts in a bovine Type I collagen lattice. It is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1-month duration and which have not adequately responded to conventional ulcer therapy. This product is also indicated for use with standard DFU care for the treatment of full-thickness neuropathic DFUs of greater than three weeks' duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.
|
Standard of Care
Standard of Care: • Coban™
* Conforming gauze
* Optifoam® non-adhesive dressing
* Cotton Gauze
* Normal saline (liquid or gel)
* Non-adhering dressings
* Steristrips
* An offloading boot (Pneumatic Short Leg Walker), as appropriate
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
5
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Withdrawal By PI
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Sponsor
|
0
|
0
|
1
|
|
Overall Study
Errant Randomization before Treatment
|
0
|
1
|
0
|
Baseline Characteristics
AMNIOEXCEL® Plus vs A Marketed Comparator vs SOC in the Management of Diabetic Foot Ulcers
Baseline characteristics by cohort
| Measure |
AMNIOEXCEL Plus Amniotic Membrane
n=41 Participants
AMNIOEXCEL Plus Amniotic Membrane: AMNIOEXCEL Plus is a human placental-based tissue consisting of dehydrated, tri-layer Placental (Amnion/Chorion/Amnion) Allograft Membrane (T-PAM) layers. T-PAM is a minimally manipulated placental membrane product made from tissues donated by pre-screened mothers during planned C-sections and is intended for use as a wound covering. This product is an allograft tissue intended for homologous use for the repair, reconstruction and replacement of skin at the direction of a physician. AMNIOEXCEL Plus contains Human Cellular and Tissue Based Products (HCT/P) as defined by US FDA 21 CFR Part 1271. All donor recoveries are performed by BioDlogics, LLC, and adhere to the regulations regarding HCT/P recovery and the screening and testing of the tissue donor as verified through supplier audits.
|
A Marketed Comparator
n=38 Participants
A Marketed Comparator: bi-layered skin substitute: the epidermal layer is formed by human keratinocytes and has a well-differentiated stratum corneum; the dermal layer is composed of human fibroblasts in a bovine Type I collagen lattice. It is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1-month duration and which have not adequately responded to conventional ulcer therapy. This product is also indicated for use with standard DFU care for the treatment of full-thickness neuropathic DFUs of greater than three weeks' duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.
|
Standard of Care
n=37 Participants
Standard of Care: • Coban™
* Conforming gauze
* Optifoam® non-adhesive dressing
* Cotton Gauze
* Normal saline (liquid or gel)
* Non-adhering dressings
* Steristrips
* An offloading boot (Pneumatic Short Leg Walker), as appropriate
|
Total
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
57.2 years
STANDARD_DEVIATION 11.32 • n=99 Participants
|
60.5 years
STANDARD_DEVIATION 11.10 • n=107 Participants
|
59.6 years
STANDARD_DEVIATION 11.03 • n=206 Participants
|
59.1 years
STANDARD_DEVIATION 11.14 • n=157 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
35 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
81 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
52 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
64 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
6 Participants
n=157 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
110 Participants
n=157 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=99 Participants
|
38 participants
n=107 Participants
|
37 participants
n=206 Participants
|
116 participants
n=157 Participants
|
PRIMARY outcome
Timeframe: Wound closure assessed up to week 12 and confirmed 2 weeks later; only participants with wound closure at or before Week 12 and who maintained closure in follow-up reportedComplete wound closure is defined as complete skin re-epithelialization that is without drainage or dressing requirements.
Outcome measures
| Measure |
AMNIOEXCEL Plus Amniotic Membrane
n=41 Participants
AMNIOEXCEL Plus Amniotic Membrane: AMNIOEXCEL Plus is a human placental-based tissue consisting of dehydrated, tri-layer Placental (Amnion/Chorion/Amnion) Allograft Membrane (T-PAM) layers. T-PAM is a minimally manipulated placental membrane product made from tissues donated by pre-screened mothers during planned C-sections and is intended for use as a wound covering. This product is an allograft tissue intended for homologous use for the repair, reconstruction and replacement of skin at the direction of a physician. AMNIOEXCEL Plus contains Human Cellular and Tissue Based Products (HCT/P) as defined by US FDA 21 CFR Part 1271. All donor recoveries are performed by BioDlogics, LLC, and adhere to the regulations regarding HCT/P recovery and the screening and testing of the tissue donor as verified through supplier audits.
|
A Marketed Comparator
n=38 Participants
A Marketed Comparator: bi-layered skin substitute: the epidermal layer is formed by human keratinocytes and has a well-differentiated stratum corneum; the dermal layer is composed of human fibroblasts in a bovine Type I collagen lattice. It is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1-month duration and which have not adequately responded to conventional ulcer therapy. This product is also indicated for use with standard DFU care for the treatment of full-thickness neuropathic DFUs of greater than three weeks' duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.
|
Standard of Care
n=37 Participants
Standard of Care: • Coban™
* Conforming gauze
* Optifoam® non-adhesive dressing
* Cotton Gauze
* Normal saline (liquid or gel)
* Non-adhering dressings
* Steristrips
* An offloading boot (Pneumatic Short Leg Walker), as appropriate
|
|---|---|---|---|
|
The Number of Participants Meeting Criteria of Complete Wound Closure, as Assessed by the Investigator at or Before Week 12 of the Treatment Phase, Which is Confirmed Closed Two Weeks Later.
|
12 Participants
|
16 Participants
|
8 Participants
|
Adverse Events
AMNIOEXCEL Plus Amniotic Membrane
Serious events: 2 serious events
Other events: 4 other events
Deaths: 0 deaths
A Marketed Comparator
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Standard of Care
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AMNIOEXCEL Plus Amniotic Membrane
n=41 participants at risk
AMNIOEXCEL Plus Amniotic Membrane: AMNIOEXCEL Plus is a human placental-based tissue consisting of dehydrated, tri-layer Placental (Amnion/Chorion/Amnion) Allograft Membrane (T-PAM) layers. T-PAM is a minimally manipulated placental membrane product made from tissues donated by pre-screened mothers during planned C-sections and is intended for use as a wound covering. This product is an allograft tissue intended for homologous use for the repair, reconstruction and replacement of skin at the direction of a physician. AMNIOEXCEL Plus contains Human Cellular and Tissue Based Products (HCT/P) as defined by US FDA 21 CFR Part 1271. All donor recoveries are performed by BioDlogics, LLC, and adhere to the regulations regarding HCT/P recovery and the screening and testing of the tissue donor as verified through supplier audits.
|
A Marketed Comparator
n=37 participants at risk
A Marketed Comparator: bi-layered skin substitute: the epidermal layer is formed by human keratinocytes and has a well-differentiated stratum corneum; the dermal layer is composed of human fibroblasts in a bovine Type I collagen lattice. It is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1-month duration and which have not adequately responded to conventional ulcer therapy. This product is also indicated for use with standard DFU care for the treatment of full-thickness neuropathic DFUs of greater than three weeks' duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.
|
Standard of Care
n=37 participants at risk
Standard of Care: • Coban™
* Conforming gauze
* Optifoam® non-adhesive dressing
* Cotton Gauze
* Normal saline (liquid or gel)
* Non-adhering dressings
* Steristrips
* An offloading boot (Pneumatic Short Leg Walker), as appropriate
|
|---|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/41 • Date of randomization through last treatment visit which could be on or before 12 weeks of treatment.
Note: A subject in the Marketed Comparator group was randomized, but not treated. This subject was removed from the study by the investigator is not counted in the AE/SAE group.
|
2.7%
1/37 • Number of events 1 • Date of randomization through last treatment visit which could be on or before 12 weeks of treatment.
Note: A subject in the Marketed Comparator group was randomized, but not treated. This subject was removed from the study by the investigator is not counted in the AE/SAE group.
|
0.00%
0/37 • Date of randomization through last treatment visit which could be on or before 12 weeks of treatment.
Note: A subject in the Marketed Comparator group was randomized, but not treated. This subject was removed from the study by the investigator is not counted in the AE/SAE group.
|
|
Infections and infestations
Diabetic Foot Infection
|
2.4%
1/41 • Number of events 1 • Date of randomization through last treatment visit which could be on or before 12 weeks of treatment.
Note: A subject in the Marketed Comparator group was randomized, but not treated. This subject was removed from the study by the investigator is not counted in the AE/SAE group.
|
0.00%
0/37 • Date of randomization through last treatment visit which could be on or before 12 weeks of treatment.
Note: A subject in the Marketed Comparator group was randomized, but not treated. This subject was removed from the study by the investigator is not counted in the AE/SAE group.
|
2.7%
1/37 • Number of events 1 • Date of randomization through last treatment visit which could be on or before 12 weeks of treatment.
Note: A subject in the Marketed Comparator group was randomized, but not treated. This subject was removed from the study by the investigator is not counted in the AE/SAE group.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/41 • Date of randomization through last treatment visit which could be on or before 12 weeks of treatment.
Note: A subject in the Marketed Comparator group was randomized, but not treated. This subject was removed from the study by the investigator is not counted in the AE/SAE group.
|
0.00%
0/37 • Date of randomization through last treatment visit which could be on or before 12 weeks of treatment.
Note: A subject in the Marketed Comparator group was randomized, but not treated. This subject was removed from the study by the investigator is not counted in the AE/SAE group.
|
2.7%
1/37 • Number of events 1 • Date of randomization through last treatment visit which could be on or before 12 weeks of treatment.
Note: A subject in the Marketed Comparator group was randomized, but not treated. This subject was removed from the study by the investigator is not counted in the AE/SAE group.
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
2.4%
1/41 • Number of events 1 • Date of randomization through last treatment visit which could be on or before 12 weeks of treatment.
Note: A subject in the Marketed Comparator group was randomized, but not treated. This subject was removed from the study by the investigator is not counted in the AE/SAE group.
|
0.00%
0/37 • Date of randomization through last treatment visit which could be on or before 12 weeks of treatment.
Note: A subject in the Marketed Comparator group was randomized, but not treated. This subject was removed from the study by the investigator is not counted in the AE/SAE group.
|
0.00%
0/37 • Date of randomization through last treatment visit which could be on or before 12 weeks of treatment.
Note: A subject in the Marketed Comparator group was randomized, but not treated. This subject was removed from the study by the investigator is not counted in the AE/SAE group.
|
Other adverse events
| Measure |
AMNIOEXCEL Plus Amniotic Membrane
n=41 participants at risk
AMNIOEXCEL Plus Amniotic Membrane: AMNIOEXCEL Plus is a human placental-based tissue consisting of dehydrated, tri-layer Placental (Amnion/Chorion/Amnion) Allograft Membrane (T-PAM) layers. T-PAM is a minimally manipulated placental membrane product made from tissues donated by pre-screened mothers during planned C-sections and is intended for use as a wound covering. This product is an allograft tissue intended for homologous use for the repair, reconstruction and replacement of skin at the direction of a physician. AMNIOEXCEL Plus contains Human Cellular and Tissue Based Products (HCT/P) as defined by US FDA 21 CFR Part 1271. All donor recoveries are performed by BioDlogics, LLC, and adhere to the regulations regarding HCT/P recovery and the screening and testing of the tissue donor as verified through supplier audits.
|
A Marketed Comparator
n=37 participants at risk
A Marketed Comparator: bi-layered skin substitute: the epidermal layer is formed by human keratinocytes and has a well-differentiated stratum corneum; the dermal layer is composed of human fibroblasts in a bovine Type I collagen lattice. It is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1-month duration and which have not adequately responded to conventional ulcer therapy. This product is also indicated for use with standard DFU care for the treatment of full-thickness neuropathic DFUs of greater than three weeks' duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.
|
Standard of Care
n=37 participants at risk
Standard of Care: • Coban™
* Conforming gauze
* Optifoam® non-adhesive dressing
* Cotton Gauze
* Normal saline (liquid or gel)
* Non-adhering dressings
* Steristrips
* An offloading boot (Pneumatic Short Leg Walker), as appropriate
|
|---|---|---|---|
|
Infections and infestations
Cellulitis
|
4.9%
2/41 • Number of events 2 • Date of randomization through last treatment visit which could be on or before 12 weeks of treatment.
Note: A subject in the Marketed Comparator group was randomized, but not treated. This subject was removed from the study by the investigator is not counted in the AE/SAE group.
|
5.4%
2/37 • Number of events 2 • Date of randomization through last treatment visit which could be on or before 12 weeks of treatment.
Note: A subject in the Marketed Comparator group was randomized, but not treated. This subject was removed from the study by the investigator is not counted in the AE/SAE group.
|
8.1%
3/37 • Number of events 3 • Date of randomization through last treatment visit which could be on or before 12 weeks of treatment.
Note: A subject in the Marketed Comparator group was randomized, but not treated. This subject was removed from the study by the investigator is not counted in the AE/SAE group.
|
|
Infections and infestations
Diabetic Foot Infection
|
4.9%
2/41 • Number of events 2 • Date of randomization through last treatment visit which could be on or before 12 weeks of treatment.
Note: A subject in the Marketed Comparator group was randomized, but not treated. This subject was removed from the study by the investigator is not counted in the AE/SAE group.
|
8.1%
3/37 • Number of events 3 • Date of randomization through last treatment visit which could be on or before 12 weeks of treatment.
Note: A subject in the Marketed Comparator group was randomized, but not treated. This subject was removed from the study by the investigator is not counted in the AE/SAE group.
|
18.9%
7/37 • Number of events 7 • Date of randomization through last treatment visit which could be on or before 12 weeks of treatment.
Note: A subject in the Marketed Comparator group was randomized, but not treated. This subject was removed from the study by the investigator is not counted in the AE/SAE group.
|
Additional Information
Jessica Knowlton, Sr Mgr, Clinical Research & PMCF Strategy
Integra LifeSciences
Phone: 609-325-0111
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators are barred from publishing or disclosing results until a multicenter publication is published or until a period of 24 months after study completion passes, whichever comes first.
- Publication restrictions are in place
Restriction type: OTHER