Diabetic Foot Ulcer
Conditions
Brief summary
This is a multicenter, randomized, parallel-group study comparing the outcomes associated with the use of AMNIOEXCEL Plus Placental Allograft Membrane, a marketed comparator and SOC alone in the management of diabetic foot ulcers (DFUs).
Interventions
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.
DEVICEA 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.
OTHERStandard 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
Sponsors
Integra LifeSciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a multicenter, randomized, parallel-group study comparing the outcomes associated with the use of AMNIOEXCEL Plus Placental Allograft Membrane, a marketed comparator and SOC alone in the management of diabetic foot ulcers (DFUs).
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Have participated in the informed consent process and signed a study-specific informed consent document. 2. Be able and willing to comply with study procedures, including study visits, study dressing regimens, and compliance with study required offloading device. 3. Be ≥ 21 years of age. 4. Have Type I or Type II diabetes mellitus with Investigator-confirmed glycosylated hemoglobin (HbA1c) of ≤ 12%. 5. Have at least one diabetic foot ulcer Ulcer size (i.e., area) is \> 1 cm2 and \< 12 cm2. 6. Have adequate vascular perfusion of the affected limb
Exclusion criteria
1. The subject was previously randomized and treated under this clinical study protocol. 2. The study ulcer has features that necessitates surgical operating-room debridement and/or penetrates to capsule/tendon/bone. 3. The subject is unable to safely ambulate with the use of a study required offloading boot. 4. The subject has suspected or confirmed gangrene or wound infection of the study ulcer. 5. The subject has suspected or confirmed osteomyelitis. 6. In the opinion of the Investigator, the subject has received or is scheduled to receive during study participation, a medication or treatment which is known to interfere with or affect the rate and quality of wound healing 7. The subject has a history of bone cancer or metastatic disease of the affected limb, radiation therapy to the foot, or has had chemotherapy prior to signing the Informed Consent Form for trial participation. 8. The subject is currently pregnant or is actively trying to conceive. 9. In the opinion of the Investigator, the subject is unable to comply with the treatment regimen 10. In the opinion of the Investigator, the subject has a history of, or is currently diagnosed with, any illness or condition, other than diabetes, that could interfere with wound healing. 11. In the opinion of the Investigator, the subject has a condition that could inhibit wound healing. 12. The subject has ulcers secondary to a disease other than diabetes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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 | Complete wound closure is defined as complete skin re-epithelialization that is without drainage or dressing requirements. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 41 |
| 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. | 38 |
| 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 | 37 |
| Total | 116 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 5 | 2 | 3 |
| Overall Study | Errant Randomization before Treatment | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 3 | 4 |
| Overall Study | Withdrawal By PI | 0 | 1 | 0 |
| Overall Study | Withdrawal by Sponsor | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | AMNIOEXCEL Plus Amniotic Membrane | Total | Standard of Care | A Marketed Comparator |
|---|---|---|---|---|
| Age, Continuous | 57.2 years STANDARD_DEVIATION 11.32 | 59.1 years STANDARD_DEVIATION 11.14 | 59.6 years STANDARD_DEVIATION 11.03 | 60.5 years STANDARD_DEVIATION 11.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 52 Participants | 20 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 64 Participants | 17 Participants | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 6 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 37 Participants | 110 Participants | 36 Participants | 37 Participants |
| Region of Enrollment United States | 41 participants | 116 participants | 37 participants | 38 participants |
| Sex: Female, Male Female | 16 Participants | 35 Participants | 6 Participants | 13 Participants |
| Sex: Female, Male Male | 25 Participants | 81 Participants | 31 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 37 | 0 / 37 |
| other Total, other adverse events | 4 / 41 | 5 / 37 | 9 / 37 |
| serious Total, serious adverse events | 2 / 41 | 1 / 37 | 2 / 37 |
Outcome results
Primary
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.
Complete wound closure is defined as complete skin re-epithelialization that is without drainage or dressing requirements.
Time frame: 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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AMNIOEXCEL Plus Amniotic Membrane | 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 |
| A Marketed Comparator | 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. | 16 Participants |
| Standard of Care | 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. | 8 Participants |