Clinical Study of ALLO-ASC-SHEET in Subjects With Diabetic Foot Ulcers

  • STATUS
    Recruiting
  • days left to enroll
    22
  • participants needed
    56
  • sponsor
    Anterogen Co., Ltd.
Updated on 16 May 2022
hydrogel
foot ulcer
necrotic debris

Summary

This is a phase 2 double-blind clinical study to evaluate the efficacy and Safety of ALLO-ASC-SHEET in subjects with Diabetic Foot Ulcers, compared to placebo therapy.

Description

  1. Active Group: ALLO-ASC-SHEET
  2. Control Group: Hydrogel SHEET (vehicle control)
  3. Study Type: Interventional
  4. Study Design: Randomized, Comparator-controlled, Double-blind, multi-center study.

Details
Condition Diabetic Foot Ulcer
Treatment ALLO-ASC-DFU, Hydrogel SHEET(Vehicle control)
Clinical Study IdentifierNCT03754465
SponsorAnterogen Co., Ltd.
Last Modified on16 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female subjects between 18 and 80 years of age
Diagnosed with Type I or Type II diabetics and has diabetic foot ulcers for longer than 4 weeks at the screening visit
Foot ulcer located in the instep, border or sole of the foot, with ulcer size between 1 cm2 and 15 cm2
Ulcer graded I by Wagner grade, and extended to skin, subcutaneous tissue, but without exposure of muscle, tendon, bone or joint capsule
Ulcer is free of necrotic debris, exhibits no signs of clinical infection
Ulcer area blood circulation meets one of the following criteria
A. Blood vessels around the ulcer detected by Doppler Test
B. range of Ankle Brachial Index(ABI) was > 0.7 to < 1.3
C. Transcutaneous oxygen pressure, (TcPO2) > 30 mmHg
Is able to give written informed consent prior to study start and to comply with the
study requirements

Exclusion Criteria

Ulcer is of non-diabetic pathophysiology
Is Human Immunodeficiency Virus (HIV) positive?
The ulcer has increased or decreased in size by ≥ 30% during the week after the Screening Visit
Have severe hepatic deficiencies
Have a glycated hemoglobin A1c (HbA1c) level of > 10%
Have allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue
Require intravenous (IV) antibiotics to treat the target wound infection
Have severe renal failure including subject on renal dialysis
Pregnant or breast-feeding
Is unwilling to use an "effective" method of contraception during the study
Have evidence of current infection including pus drainage from the wound site
Have a clinically relevant history of alcohol or drugs abuse
Have postprandial blood sugar > 350 mg/dl
Is not able to understand the objective of this study or to comply with the study requirements
Is considered by the investigator to have a significant disease which might have impacted the study
Is considered not suitable for the study by investigator
Have a history of malignancy within the last five years (except basal cell carcinoam in situ)
Is currently or were enrolled in another clinical study within 60 days of screening
Have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days
Is receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents with unstable dose prior to 4 weeks from screening
Cannot maintain off-loading process
Panel reactive antibody (PRA) levels ≥ 20%
Clear my responses

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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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