Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05024656
Other study ID # T-AEPDFU-002
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date September 2021
Est. completion date June 2024

Study information

Verified date October 2021
Source Integra LifeSciences Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a prospective, multicenter, randomized, parallel-group Trial comparing the outcomes associated with the use of AmnioExcel® Plus Placental Allograft Membrane (AmnioExcel® Plus) used in conjunction with Standard of Care (SOC) compared to SOC alone in the management of diabetic foot ulcers (DFUs).


Description:

This study will have three (3) phases: (1) a Screening Phase, (2) a Treatment Phase, and (3) a Follow-up Phase. Subjects will be seen weekly in the Screening and Treatment Phases. Subjects will be seen weekly in the Screening and Treatment Phases. Subjects who achieve confirmed wound closure during the Treatment Phase will be entered into the Follow-up Phase and will return to the site four (4) weeks following that confirmation visit.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2024
Est. primary completion date February 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Have participated in the informed consent process and signed a study-specific informed consent document - Be willing to comply with study procedures, including study visits, and compliance with study required off-loading/protective device for the duration of the study - Be at least 18 years of age - If female and of child-bearing potential, must not be pregnant. To document pregnancy status, subject statement is acceptable - Have Type II or Type II diabetes mellitus with investigator-confirmed glycosylated hemoglobin (HbA1c) of less than or equal to 12% within 3 months prior to Screening Visit - Have at least one diabetic foot ulcer that meets ALL the following criteria: 1. Ulcer which has been in existence for a minimum of four weeks, prior to signing the Informed Consent Form allowing trial participation 2. Ulcer is a partial or full thickness diabetic foot ulcer without capsule/tendon/bone exposure 3. Ulcer does not have tunneling, undermining, or sinus tracts that necessitates surgical OR debridement and/or penetrates to capsule/tendon/bone 4. Ulcer is located on the foot or ankle (with no portion above the top of the malleolus) 5. Ulcer size (area) is greater than equal to 1 cm2 and less than equal to 12 cm2 post-debridement - Have a minimum 4cm margin between the qualifying study ulcer and any other ulcer on that same foot, post-debridement (a) If the subject has more than one ulcer that meets eligibility criteria, the ulcer designated as the study ulcer will be at the discretion of the investigator - Have adequate vascular perfusion of the affected limb as defined by at least one of the following within the past 60 days: 1. Ankle-Brachial Index (ABI) greater than equal to 0.7 and less than equal to 1.2, performed within 60 days of screening, 2. Toe pressure (plethysmography) > 40 mmHg at time of screening, or 3. TcPO2 > 50 mmHg at time of screening - Be willing and able to maintain required applicable dressing changes as well as study required off-loading/protective device for the duration of the study - Have a study wound severity Wagner I or II Exclusion Criteria: - Previously randomized and treated under this clinical study protocol - Patients with a known history of poor compliance with medical treatments - Suspected or confirmed gangrene or ulcer infection of the study ulcer or is receiving systemic/IV antibiotics at the time of randomization - Suspected or confirmed osteomyelitis of the foot with the study ulcer - Participated in another clinical trial involving a device or a systemically administered investigational study drug/treatment within 28 days of randomization - Received within 28 days of signing Informed Consent Form, 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 ulcer healing (e.g., systemic steroids, immunosuppressive therapy, autoimmune disease therapy, dialysis, radiation therapy to the foot, vascular surgery, angioplasty, or thrombolysis) - History of bone cancer or metastatic disease of the affected limb, radiation therapy to the foot, or has had chemotherapy (i.e., systemic steroids, anti-rheumatics, TNF inhibitors, active chemotherapy, immunosuppressive therapy, autoimmune disease therapy) within 12 months prior to signing Informed Consent Form allowing trial participation - 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 ulcer healing (e.g., end-stage renal disease, severe malnutrition, liver disease, aplastic anemia, connective tissue disorder, acquired immune deficiency syndrome, HIV positive, or sickle cell anemia) - In the opinion of the investigator, the subject has unstable Charcot foot or Charcot with bony prominence that could inhibit ulcer healing - Have ulcers secondary to a disease other than diabetes (e.g., vasculitis, neoplasms, or hematological disorders) - In the opinion of the investigator, the subject has excessive lymphedema that could interfere with off-loading and/or ulcer healing - Study Ulcer has received ulcer dressings that included growth factors, engineered tissues, or skin substitutes within 28 days of randomization, or is scheduled to receive such treatment during the study (e.g., Regranex, Dermagraft, Apligraf, EpiFix, Grafix, GraftJacket, OASIS, Omnigraft, or Integra BMWD)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
AmnioExcel Plus Amniotic Membrane
AmnioExcel® Plus will be applied weekly, in conjunction with SOC, if the ulcer remains open, or up to and including Week 11, whichever comes first.
Standard of Care
The dressings, materials, and appliances used in accordance with institutional protocol or professional clinical judgement.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Integra LifeSciences Corporation

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of complete wound closure Number of wounds with complete wound closure as assessed by the investigator. Complete wound closure is defined as 100% re-epithelialization of the ulcer surface without detectable exudate. Up to 12 weeks of treatment
See also
  Status Clinical Trial Phase
Recruiting NCT04497805 - Clinical Study of ALLO-ASC-SHEET in Subjects With Diabetic Wagner Grade II Foot Ulcers Phase 2
Withdrawn NCT03675269 - Adjunctive Hyperbaric Oxygen Therapy (HBOT) for Lower Extermity Diabetic Ulcer: N/A
Completed NCT04624516 - Effect of Self-foot Exercise on the Incidence of Plantar Foot Diabetic Ulcer Recurrence N/A
Not yet recruiting NCT06439667 - VIRTUALLY SUPERVISED TELE-EXERCISE PLATFORM FOR ACCELERATING PLANTAR WOUND HEALING
Recruiting NCT05608187 - Evaluating Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers Phase 2
Not yet recruiting NCT06278935 - Lifestyle Tailored Offloading for Diabetic Foot Ulcers N/A
Not yet recruiting NCT06437028 - Evaluating the Efficacy of Perinatal Membrane Allografts for the Treatment of Diabetic Foot Ulcers. N/A
Terminated NCT02202668 - Transcutaneous Raman Spectroscope (TRS) Analyses of Diabetic Foot Ulcers N/A
Terminated NCT01966380 - Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia Phase 2
Completed NCT01951768 - Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection Phase 4
Completed NCT01657474 - Comparative Study of Two Application Regimens of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers N/A
Active, not recruiting NCT00389636 - TheraGauzeā„¢ Alone and Regranex®Gel 0.01% Plus TheraGauzeā„¢ in the Treatment of Wagner Stage I Diabetic Foot Ulcers N/A
Completed NCT01181440 - Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers Phase 3
Enrolling by invitation NCT05888259 - Plantar Pressure Distribution in Diabetic Foot Ulcer N/A
Completed NCT04054804 - Digital Foot Check by Using the D-Foot, a New Software
Not yet recruiting NCT05877378 - Efficacy of PICO Single-use System in Chronic Ulcers N/A
Recruiting NCT06037369 - The Short Message-based Customized Standardized N/A
Completed NCT03312595 - Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU) N/A
Recruiting NCT04564443 - A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot N/A
Not yet recruiting NCT06444906 - A Two-Part, Randomized Study of Dermacyte® Amniotic Wound Care Matrix N/A