NCT03259217

Brief Summary

This study will assess the efficacy of application of stem cell in healing of chronic diabetic foot ulcer

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2017

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

August 21, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 23, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

August 23, 2017

Status Verified

August 1, 2017

Enrollment Period

9 months

First QC Date

August 21, 2017

Last Update Submit

August 21, 2017

Conditions

Stem Cell Transplant

Outcome Measures

Primary Outcomes (1)

  • complete healing

    full epithelization of chronic diabetic foot ulcer

    6 months

Secondary Outcomes (2)

  • Rate of healing

    6 months

  • rate of ulcer recurrence

    one year

Study Arms (1)

stem cell product

EXPERIMENTAL

stem cell transplant

Drug: Stem Cell Product

Interventions

Stem Cell ProductDRUG

Adipose tissue derived mesenchymal stem cell seeded in Curcumin loaded chitosan nanoparticles into collagen-alginate

Also known as: mesenchymal stem cells
stem cell product

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetic patient with diagnosis of neuropathic or neuro-ischemic DFU
  • Chronic non healed diabetic foot ulcer (The wound was determined as non-healing and chronic when the wound was treated with current standard care for diabetic foot ulcer by a wound care specialist for at least 3 months prior to the therapy with less than 40% of wound closure)
  • Strict diabetes control with HbA1c ≤ 7.5%
  • Grade 1 or 2 ulcer on the Wagner scale

You may not qualify if:

  • Critical ischemia of the target limb, defined by pain at rest and an ankle systolic pressure \< 50 mm Hg, or a toe systolic pressure \< 30 mm Hg 2- DFU clinically infected as defined by the IDSA/IWGDF criteria, osteomyelitis confirmed by MRI, or other evidence of infection is present 3- Surgery or surgical revascularisation \< 2months 4- Collagen tissue diseases , malignant and hematological diseases onset of myocardial infarction or cerebral infarction within the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Sener LT, Albeniz I. Challenge of Mesenchymal Stem Cells Against Diabetic Foot Ulcer. Curr Stem Cell Res Ther. 2015;10(6):530-4. doi: 10.2174/1574888x10666150519092931.

    PMID: 25986622RESULT

Study Officials

  • Walaa Khalifa, MD

    lecturer

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Walaa Khalifa, MD

CONTACT

+20882303620dr.walaaanwar@yahoo.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR

Study Record Dates

First Submitted

August 21, 2017

First Posted

August 23, 2017

Study Start

October 1, 2017

Primary Completion

July 1, 2018

Study Completion

January 1, 2019

Last Updated

August 23, 2017

Record last verified: 2017-08