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Clinical Study of Adipose-derived Stem Cells in the Treatment of Diabetic Foot

NCT03916211 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-04-16

No results posted yet for this study

Summary

1. Program Name: Clinical Study on Treatment of Diabetic Foot with Autologous Adipose Stem Cells
2. Bidding Unit: Tenth People's Hospital Affiliated to Tongji University
3. Study subjects: diabetic foot patients
4. OBJECTIVE: To establish an autologous adipose stem cell therapy for diabetic foot and evaluate its clinical safety and efficacy.
5. Study Design: Randomized Controlled Clinical Study
6. Target number of cases: 60
7. Main evaluation indicators: ulcer healing and amputation, calculating ulcer healing rate = total wound healing cases / total ulcer cases in this group; amputation rate = amputation cases / total cases in this group.
8. Secondary evaluation indicators: ankle-brachial index (ABI), Ruthford classification, painless walking time Wong-Baker Faces pain score, transcutaneous partial pressure of oxygen (TcPO2), laser Doppler flowmetry, multi-slice spiral CT angiography (CTA)

Conditions

  • Diabetes Mellitus Foot Ulcer

Interventions

BIOLOGICAL

MSCs treatment

intramuscular injection of adipose stem cells treat diabetic foot

Sponsors & Collaborators

  • Maoquan Li

    lead OTHER

Principal Investigators

  • Li Xue, ph.D · Shanghai 10th People'sHospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-20
Primary Completion
2020-01-31
Completion
2020-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03916211 on ClinicalTrials.gov