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Cell Therapy for Diabetic Foot Ulcer

Primary Purpose

Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus, Wound Heal

Status
Recruiting
Phase
Phase 2
Locations
Chile
Study Type
Interventional
Intervention
InbioDerm + C plus advanced healing
Advanced healing
Sponsored by
Instituto para el Desarrollo Biotecnológico y la Innovación S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient over 18 years old and under 75 years old.
  • Patient diagnosed with DM type II.
  • Patient with negative pregnancy test.
  • Ulcer size with area between 1 cm2 and 12 cm2.
  • Ulcer with Wagner grade II classification with less than 50% slough and no tendon exposure, validated by an external specialist after ulcer debridement.
  • Ulcer age ≥ at one month.
  • Patients with palpable posterior tibial and pedial pulse

Exclusion Criteria:

  • Patients with non-diabetic ulcers.
  • Toe ulcers.
  • Patient with grade IV and V renal insufficiency.
  • Pregnant or breastfeeding women, or those who are planning to conceive children.
  • Clinical evidence of infection.
  • Any condition or circumstance that might interfere with adherence to the treatment regimen (compliance with scheduled visits, psychiatric disorders, or drug and/or alcohol abuse)
  • History of hepatitis B or hepatitis C and HIV (by internal laboratory biosafety protocols)
  • Allergy to penicillin, streptomycin, and gentamicin
  • Subjects undergoing treatment with immunosuppressants and corticoids.
  • Subjects on anticoagulant treatment with acenocoumarol and warfarin.
  • Having received any experimental treatment in the last three months (drug, biological product, medical device or cell therapy), except for the use of vaccines administered against COVID-19 (e.g. mRNA technologies, viral vector or inactivated virus).

Sites / Locations

  • Centro de Salud Familiar de Villa AlemanaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Advanced Healing

InbioDerm + C plus advanced healing

Arm Description

Activities related to wound washing, microbiological load control, care of peri-ulcer tissue and application of wound healing products in accordance to condition of the ulcer

For patient who are assigned treatment with InbioDerm+C plus advanced healing a section of skin tissue and peripheral venous blood will be taken. From the skin section and through an enzymatic process with cell proliferation, skin cells will be obtained that will be integrated into de the InbioDerm+C, then will be apply to the patients with the advanced wound healing every fourteen days in accordance application program.

Outcomes

Primary Outcome Measures

Proportion of patients with completely closed ulcers
The principal investigation and external evaluator will assess every fifteen days the wound closure status.

Secondary Outcome Measures

Full Information

First Posted
January 31, 2022
Last Updated
February 1, 2022
Sponsor
Instituto para el Desarrollo Biotecnológico y la Innovación S.A.
Collaborators
Corporación de Fomento de la Producción, Chile
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1. Study Identification

Unique Protocol Identification Number
NCT05234086
Brief Title
Cell Therapy for Diabetic Foot Ulcer
Official Title
Randomized, Controlled Phase II Clinical Study to Evaluate Superiority of "InbioDerm+C" Autologous Stem Cell-Based Therapy Plus Advanced Healing Compared With Advanced Healing in Diabetic Foot Ulcer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 2, 2020 (Actual)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
September 2, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto para el Desarrollo Biotecnológico y la Innovación S.A.
Collaborators
Corporación de Fomento de la Producción, Chile

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Diabetes is a highly prevalent chronic disease that affects a large part of the world's population. Among the most costly complications is the diabetic foot ulcer, where its decompensation can result in limb amputation, a risk 10 to 20 times more frequent for diabetic population. Two underlying pathophysiological mechanisms are mainly identified: neuropathy and problems associated with vasculature and blood supply, in addition to the incidence of infections, which further impairs prognosis. Skin regeneration involves several overlapping and consecutive stages, which in the case of a diabetic patient are altered. Although healing protocols have been significantly improved at the country level, and there is also a large amount of medical supplies for treatment of these wounds, there are still patients with ulcers refractory to this care that end in amputation. In response to this, new treatments have emerged that use biomaterials and cells of the patient himself, which attempt to emulate the architecture and functionality of normal tissue. Cell therapy has gained strength in recent years, with more and more studies indicating the positive effect of cell application on healing of chronic wounds with underlying pathologies, such as diabetes. The product to be evaluated corresponds to a combined medical device, which conveys a cellular therapy, known as InbioDerm+C. The purpose of this Phase II clinical study is to determine whether InbioDerm+C treatment plus advanced healing is equal to or superior to advanced healing in a diabetic population with Wagner II grade foot ulcer treated in Villa Alemana primary care family centers, Las Américas, Juan Bautista Bravo Vega and Eduardo Frei.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus, Wound Heal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The assessor will evaluate encrypted images and tables containing healing valoration data.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Advanced Healing
Arm Type
Active Comparator
Arm Description
Activities related to wound washing, microbiological load control, care of peri-ulcer tissue and application of wound healing products in accordance to condition of the ulcer
Arm Title
InbioDerm + C plus advanced healing
Arm Type
Experimental
Arm Description
For patient who are assigned treatment with InbioDerm+C plus advanced healing a section of skin tissue and peripheral venous blood will be taken. From the skin section and through an enzymatic process with cell proliferation, skin cells will be obtained that will be integrated into de the InbioDerm+C, then will be apply to the patients with the advanced wound healing every fourteen days in accordance application program.
Intervention Type
Combination Product
Intervention Name(s)
InbioDerm + C plus advanced healing
Intervention Description
For patients who are assigned to experimental treatment with InbioDerm+C plus advanced healing a section of skin tissue and peripheral venous blood will be taken. From the skin section, through an enzymatic process and cell proliferation for a period of approximately fourteen days, the cells that are integrated in the InbioDerm+C will be obtained and used to treat the foot ulcer.
Intervention Type
Procedure
Intervention Name(s)
Advanced healing
Intervention Description
Patients who are assigned to active comparator correspond to the control treatment, which will be received advanced healing.
Primary Outcome Measure Information:
Title
Proportion of patients with completely closed ulcers
Description
The principal investigation and external evaluator will assess every fifteen days the wound closure status.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient over 18 years old and under 75 years old. Patient diagnosed with DM type II. Patient with negative pregnancy test. Ulcer size with area between 1 cm2 and 12 cm2. Ulcer with Wagner grade II classification with less than 50% slough and no tendon exposure, validated by an external specialist after ulcer debridement. Ulcer age ≥ at one month. Patients with palpable posterior tibial and pedial pulse Exclusion Criteria: Patients with non-diabetic ulcers. Toe ulcers. Patient with grade IV and V renal insufficiency. Pregnant or breastfeeding women, or those who are planning to conceive children. Clinical evidence of infection. Any condition or circumstance that might interfere with adherence to the treatment regimen (compliance with scheduled visits, psychiatric disorders, or drug and/or alcohol abuse) History of hepatitis B or hepatitis C and HIV (by internal laboratory biosafety protocols) Allergy to penicillin, streptomycin, and gentamicin Subjects undergoing treatment with immunosuppressants and corticoids. Subjects on anticoagulant treatment with acenocoumarol and warfarin. Having received any experimental treatment in the last three months (drug, biological product, medical device or cell therapy), except for the use of vaccines administered against COVID-19 (e.g. mRNA technologies, viral vector or inactivated virus).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Soledad Herrera
Phone
56966083093
Email
soledadherrera@inbiocriotec.cl
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Weinstein-Oppenheimer
Phone
56322508140
Email
caroline.weinstein@uv.cl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franco Ahumada
Organizational Affiliation
Centro de Salud Familiar Villa Alemana
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Salud Familiar de Villa Alemana
City
Villa Alemana
State/Province
Valparaíso
ZIP/Postal Code
2550880
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franco Ahumada, MD
Phone
56965487096
Email
franco.ahumada@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Cell Therapy for Diabetic Foot Ulcer

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