Cell Therapy for Diabetic Foot Ulcer

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Diabetes Mellitus, Type 2
Diabetic Foot
Diabetic Foot Ulcer Associated With Type II Diabetes Mellitus
Foot Ulcer
Ulcer
Wound Heal

Clinical Trial Details

NCT number	NCT05234086
Study type	Interventional
Source	Instituto para el Desarrollo Biotecnológico y la Innovación S.A.
Contact	Soledad Herrera
Phone	56966083093
Email	soledadherrera@inbiocriotec.cl
Status	Recruiting
Phase	Phase 2
Start date	January 2, 2020
Completion date	September 2, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05023135` - DeepView SnapShot Portable (DV-SSP): Device Training Study
Recruiting	`NCT03459547` - Soft Peri-implant Tissue Around Different Abutment Materials	N/A
Recruiting	`NCT05608187` - Evaluating Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers	Phase 2
Active, not recruiting	`NCT03649308` - Negative Pressure Wound Therapy Compared to Traditional Care After Skin Grafting	N/A
Recruiting	`NCT04596124` - Effectiveness and Tolerability of Fitostimoline Plus Cream and Gauze vs Connettivina Bio Plus Cream and Gauze	N/A
Completed	`NCT03285542` - Prospective Randomized Trial of Dermabond Prineo in Total Knee Arthroplasty	N/A
Recruiting	`NCT05474911` - PILONIDAL SINUS: CONVENTIONAL CARE VERSUS NEGATIVE PRESSURE THERAPY.	N/A
Recruiting	`NCT05689775` - Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap
Recruiting	`NCT04849143` - The Effectiveness of Stingless Bee Honey (Kelulut Honey) Versus Gel in Diabetic Wound Bed Preparation	N/A
Completed	`NCT03596112` - The Difference in Wound Size Reduction Comparing Two Frequently Used Wound Dressings in Everyday Care	N/A
Recruiting	`NCT05169814` - Micro/Nanobubbles (MNBs) for Treatment of Acute and Chronic Wounds	Early Phase 1
Completed	`NCT04545476` - Enhanced Secondary Intention Healing vs. Standard Secondary Intention Healing in Mohs Surgical Defects on the Head and Distal Lower Extremities	N/A
Completed	`NCT06020157` - Comparison of Simple and Continuous Suture Techniques in Oral Surgery	N/A
Recruiting	`NCT05133570` - Study Evaluating the Effectiveness of Treatment With Vista Care®, in Arterial Ulcers of the Lower Extremities
Recruiting	`NCT04901325` - Baricitinib in the Treatment of Adults With Pyoderma Gangrenosum (PG)	Phase 2
Withdrawn	`NCT03668665` - Influencing Wound Healing Through the Application of Hyaluronic Acid With Perfluorodecalin and Physalis Angulata Extract After Split Skin Removal From the Thigh - A Study in "Split Wound Design"	Phase 3
Completed	`NCT03703479` - Effect of A-PRF After Removal of Wisdom Teeth	N/A
Recruiting	`NCT03204851` - Microlyte Dressing in the Management of Wounds	N/A
Recruiting	`NCT06117436` - Impact of Cilostazol Versus Cilostazol and Selenium Combination on the Healing of Diabetic Foot Ulcer Patients	Phase 2/Phase 3
Completed	`NCT05618912` - Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.