PRG Combined With Autologous BMMSCs for Treatment of Diabetic Foot Ulcer

Transplantation of Autologous Platelet Rich Gel Combined With Autologous Bone Marrow Mesenchymal Stem Cells for Treatment of Diabetic Foot Ulcer

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03248466

Enrollment

Registered

2017-08-14

Start date

2017-08-30

Completion date

2020-07-01

Last updated

2017-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Foot Ulcer

Keywords

platelet rich gel, BMMSCs, diabetic foot ulcer

Brief summary

To investigate the treatment effect between Traditional treatment and transplantation of autologous PRG combined with autologous BMMSCs for treatment of diabetic foot ulcer.

Detailed description

60 diabetic foot ulcer in our hospital will divide into 3 groups: group A (20 diabetic foot ulcer who give Traditional treatment), group B (20 diabetic foot ulcer who give Traditional treatment and transplantation of autologous platelet rich gel)，group C (20 diabetic foot ulcer who give Traditional treatment and transplantation of autologous platelet rich gel combined with autologous bone marrow mesenchymal stem cells). The age, height, weight, blood glucose, glycosylated hemoglobin A1c（HbA1c）, lipid, blood pressure, course of disease, Wound healing rate,transcutaneous oxygen pressure,Amputation rate,Hospital stay will record respectively. And High-sensitive C-reactive protein (HsCRP) and Tumor necrosis factor-α（TNF-α） will detect as Baseline. After each group's treatment, Change from baseline of all indexes will record, one way Analysis of Variance will be analyzed the significantion among 3 groups.

Interventions

BIOLOGICALPRG combined with BMMSCs transplantation

PRG combined with BMMSCs transplantation

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Intervention model description

diabetic foot ulcer which Wagner classification at 2-3 grade.

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Diabetic foot according to The Wagner is 2-3 graded;

Exclusion criteria

* Type 1 diabetes mellitus,presence of autoimmune diabetes; * Gestational diabetes; * Patients with heart, liver, or renal function impairment;presence of severe infections or cerebrovascular disease.

Design outcomes

Primary

Measure	Time frame	Description
Amputation rate	up to 6 months	Amputation rate up to 6 months
hospital stay	up to 6 months	hospital stay

Secondary

Measure	Time frame	Description
Wound healing time	up to 6 months	Wound healing time
Transcutaneous oxygen partial pressure	Transcutaneous oxygen partial pressure up to 6 months	Transcutaneous oxygen partial pressure

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026