NCT04464213

Brief Summary

This study is designated to:

  1. 1.investigate the tolerance and safety of treatment of Human placental mesenchymal stem cells gel on Human diabetic foot ulcer.
  2. 2.learn the primary effectiveness of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.
  3. 3.study the pharmacokinetics of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
43

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2020

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

October 21, 2022

Status Verified

December 1, 2021

Enrollment Period

2.7 years

First QC Date

July 7, 2020

Last Update Submit

October 19, 2022

Conditions

Diabetic Foot Ulcer

Keywords

Human placental mesenchymal stem cellsGel

Outcome Measures

Primary Outcomes (2)

  • Rate of adverse event

    The rate of adverse event in 24 hours after single dose of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.

    0 hour - 24 hours

  • Rate of adverse event

    The rate of adverse event in 7 days after multi-dose of Human placental mesenchymal stem cells gel on Human diabetic food ulcer.

    0 Day - 7 Days

Secondary Outcomes (2)

  • Rate of serious adverse event

    0 hour - 1 hour

  • Rate of cure rate

    0 day - 34 days

Study Arms (2)

Single dose experiments

EXPERIMENTAL
Other: Single dose experiments

Multi-dose experiments

EXPERIMENTAL
Other: Multi-dose experiments

Interventions

Single dose experimentsOTHER

In single dose experiments, after clean the diabetic foot ulcer, paint the Human placental mesenchymal stem cells gel on the wound, each patient only receive treatment once time.

Single dose experiments
Multi-dose experimentsOTHER

In multi-dose experiments, after clean the diabetic foot ulcer, paint the Human placental mesenchymal stem cells gel on the wound, each patient receive treatment on six consecutive days.

Multi-dose experiments

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 and Age ≤ 75
  • Type 1 or type 2 diabetes mellitus, glycosylated hemoglobin ≤ 9.0%
  • Diagnosed as condition of diabetic foot ulcer, Wagner grade at 1 or 2 after clinical treatment
  • Full understand the informed consent form, and signed it voluntarily

You may not qualify if:

  • Pregnant or breast-feed women or plan to pregnant or fail to take an efficient contraception
  • Be allergic to any component of the drug or showed allergic constitution
  • Showed a sign of systemic infection, or with complication of ethmyphitis, or osteomyelitis indicated by MRI
  • Have malignancy in the ulcer pathology test, or have a history of malignant tumor
  • Unable to clean the wounds due to the formation of tract between the ulcer and other condition
  • Infected with hepatitis B virus (HBV), hepatitis virus C (HCV), human immunodeficiency virus (HIV), or treponema pallidum
  • Alanine transaminase (ALT) or aspartate transaminase (AST) exceeds 2.5 times of the normal value, or Cr\>200 μmol/L
  • Have a history of apoplexy, unstable angina pectoris, myocardial infarct
  • Have a psychiatric history, drug abuse or alcohol abuse history
  • Had participated in any other clinical trials in the past 3 months
  • Any other circumstances judged by the researchers disqualify the patient to participate in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute for Drug Clinical Trial, Beijing Tongren Hospital, Capital Medical University

Beijing, Beiijng, 100730, China

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic AngiopathiesVascular DiseasesCardiovascular DiseasesFoot UlcerLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesDiabetic Neuropathies

Study Officials

  • Xiuli Zhao, Doc

    Beijing Tongren Hospital, CMU

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Siyang Ni, Doc

CONTACT

+(86)-18911810275grandnsy@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2020

First Posted

July 9, 2020

Study Start

November 1, 2020

Primary Completion

August 1, 2023

Study Completion

December 31, 2023

Last Updated

October 21, 2022

Record last verified: 2021-12

Locations

CN(1)