Clinical Study of Adipose-derived Stem Cells in the Treatment of Diabetic Foot
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|ClinicalTrials.gov Identifier: NCT03916211|
Recruitment Status : Not yet recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
- Program Name: Clinical Study on Treatment of Diabetic Foot with Autologous Adipose Stem Cells
- Bidding Unit: Tenth People's Hospital Affiliated to Tongji University
- Study subjects: diabetic foot patients
- OBJECTIVE: To establish an autologous adipose stem cell therapy for diabetic foot and evaluate its clinical safety and efficacy.
- Study Design: Randomized Controlled Clinical Study
- Target number of cases: 60
- Main evaluation indicators: ulcer healing and amputation, calculating ulcer healing rate = total wound healing cases / total ulcer cases in this group; amputation rate = amputation cases / total cases in this group.
- Secondary evaluation indicators: ankle-brachial index (ABI), Ruthford classification, painless walking time Wong-Baker Faces pain score, transcutaneous partial pressure of oxygen (TcPO2), laser Doppler flowmetry, multi-slice spiral CT angiography (CTA)
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Foot Ulcer||Biological: MSCs treatment||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Study of Adipose-derived Stem Cells in the Treatment of Diabetic Foot|
|Estimated Study Start Date :||April 20, 2019|
|Estimated Primary Completion Date :||January 31, 2020|
|Estimated Study Completion Date :||March 31, 2020|
No Intervention: routine treatment
Diabetic foot routine treatment without intervention
Experimental: MSCs treatment
On the basis of routine treatment of diabetic foot, adipose stem cells will be added to treat diabetic foot
Biological: MSCs treatment
intramuscular injection of adipose stem cells treat diabetic foot
- ulcer healing rate [ Time Frame: up to 4 weeks ]Ulcer healing rate = number of cases of complete wound healing / total number of ulcers in this group
- amputation rate [ Time Frame: up to 4 weeks ]Amputation rate = number of amputations / total number of amputations in this group
- ultrasound [ Time Frame: 2 weeks ]Evaluate patients' limbs blood flow by ultrasound，We will record blood flow velocities, for example， 4ml/second.
- ABI(ankle brachial index) [ Time Frame: 2weeks ]The ratio of ankle artery pressure to brachial artery pressure was obtained by measuring the contractile pressure of the posterior tibial artery, anterior tibial artery and brachial artery of the ankle.ABI≥0.9 means normal,0.8≥ABI≥0.7means mild arterial obstruction,0.6≥ABI≥0.4means moderate arterial obstruction,ABI<0.4means severe arterial obstruction.
- TcPO2（Transcutaneous oxygen pressure） [ Time Frame: 2 weeks ]Evaluate patients'oxygen level by TcPO2,TcPO2<20mmHg means very severe lesion.
- CTA(Computed Tomography angiography) [ Time Frame: up to 4 weeks ]Evaluate patients' limbs blood flow by CTA,We will record blood flow velocities, for example， 4ml/second.
- Rutherford Classification [ Time Frame: 2 weeks ]Evaluate patients' limbs blood flow by Rutherford classification，Grade 0: Normal Grade 1: Walking over 500 meters with lameness Grade 2: Walking 200-500 meters with lameness Grade 3: Walking within 200 meters with lameness Grade 4: Resting pain Grade 5: Small ulcer Grade 6: Large ulcer.
- Wong-Baker Faces Pain Rating Scale [ Time Frame: up to 4 weeks ]Evaluate patients' degree of pain by Wong-Baker Faces Pain Rating Scale.There are 6 faces in the Wong-Baker Pain Scale. The first face represents a pain score of 0, and indicates "no hurt". The second face represents a pain score of 2, and indicates "hurts a little bit." The third face represents a pain score of 4, and indicates "hurts a little more". The fourth face represents a pain score of 6, and indicates "hurts even more". The fifth face represents a pain score of 8, and indicates "hurts a whole lot"; the sixth face represents a pain score of 10, and indicates "hurts worst.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916211
|Contact: Li Maoquan, ph.Dfirstname.lastname@example.org|
|Contact: Xie Xiaoyun, ph.Demail@example.com|
|Study Director:||Li Xue, ph.D||Shanghai 10th People'sHospital|