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
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Proportion of patients with completely closed ulcers
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessor will evaluate encrypted images and tables containing healing valoration data.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 cm
- •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
排除标准
- •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).
结局指标
主要结局
Proportion of patients with completely closed ulcers
时间窗: 16 weeks
The principal investigation and external evaluator will assess every fifteen days the wound closure status.
次要结局
未报告次要终点
研究者
Soledad Herrera
Regulatory Affairs - Inbiocriotec
Instituto para el Desarrollo Biotecnológico y la Innovación S.A.