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This project adopts a prospective clinical trial study to compare and evaluate the efficacy of local transplantation of human umbilical cord mesenchymal stem cells combined with silver ion dressing and simple silver ion dressing in the treatment of venous lower extremity ulcer wounds. To improve the healing rate and quality of life of patients.
Chronic wounds refer to the pathological changes such as cell senescence, imbalance of synthesis and degradation of extracellular matrix, and decreased activity of growth factors caused by different reasons when the wound is prolonged and does not heal after conventional treatment for more than 1 month without healing tendency. Chronic wound can be caused by a variety of diseases, including arterial disease, diabetes, vasculitis, venous disease and skin malignant tumor, chronic venous insufficiency (CVI) is a disease leading to chronic wound, Venous ulcer (VLU) of lower limbs is the advanced manifestation of CVI, and the incidence of this disease ranges from 0.4% to 1.3% in China. 60% of VLU patients' ulcer wounds heal in 3-6 months, 33% in 12 months, and 7% May be permanently unhealed. The probability of recurrence is as high as 70% in patients 3-5 months after wound healing, which not only seriously affects the health and quality of life of patients, but also causes a very heavy social medical burden. At present, the conventional treatment for VLU mainly includes drug therapy, stress therapy, wound treatment and surgical treatment, but the therapeutic effect is not ideal.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stem cell preparation combined with silver ion dressing | Experimental |
| |
| silver ion dressing | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stem cell preparation combined with silver ion dressing | Other | The dosage range of each cm2 ulcer wound is (1~5)×10^6. The dosage of human umbilical cord mesenchymal stem cells for the second treatment is determined according to the severity of the ulcer. Each patient is treated for 2 consecutive times, and the interval between each treatment is 3 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Healing time | The time required for the wound healing rate to reach 100% | Epithelialization of the wound completely or 24 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Wound shrinkage rate | Grid method was used to calculate the wound area, with 1 decimal place behind the length unit and 2 decimal places behind the area unit. The wound edges before, during and after treatment were depicted on the transparent mesh film respectively, and the original wound area and the unhealed wound area were calculated. Wound shrinkage rate = (initial area of wound - area measured on the day)/original area of wound × 100% |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Hospital, Army Medical University (Third Military Medical University) | Recruiting | Chongqing | Chongqing Municipality | 400038 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32636985 | Result | Alvarez OM, Markowitz L, Parker R, Wendelken ME. Faster Healing and a Lower Rate of Recurrence of Venous Ulcers Treated With Intermittent Pneumatic Compression: Results of a Randomized Controlled Trial. Eplasty. 2020 Jun 5;20:e6. eCollection 2020. | |
| 31970660 | Result | Nicolaides AN. The Most Severe Stage of Chronic Venous Disease: An Update on the Management of Patients with Venous Leg Ulcers. Adv Ther. 2020 Feb;37(Suppl 1):19-24. doi: 10.1007/s12325-020-01219-y. Epub 2020 Jan 22. |
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| ID | Term |
|---|---|
| D014647 | Varicose Ulcer |
| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
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|
| silver ion dressing | Procedure | fter wound debridement, a silver ion dressing suitable for the size of the wound was cut and covered on the wound bed. Sterile gauze was covered on the silver ion dressing and fixed with adhesive tape. |
|
| Epithelialization of the wound completely or 24 weeks after treatment |
| 34829797 | Result | Aleksandrowicz H, Owczarczyk-Saczonek A, Placek W. Venous Leg Ulcers: Advanced Therapies and New Technologies. Biomedicines. 2021 Oct 29;9(11):1569. doi: 10.3390/biomedicines9111569. |
| 30775606 | Result | Kavala AA, Turkyilmaz S. Autogenously derived regenerative cell therapy for venous leg ulcers. Arch Med Sci Atheroscler Dis. 2018 Dec 15;3:e156-e163. doi: 10.5114/amsad.2018.81000. eCollection 2018. |
| 30583949 | Result | Zollino I, Campioni D, Sibilla MG, Tessari M, Malagoni AM, Zamboni P. A phase II randomized clinical trial for the treatment of recalcitrant chronic leg ulcers using centrifuged adipose tissue containing progenitor cells. Cytotherapy. 2019 Feb;21(2):200-211. doi: 10.1016/j.jcyt.2018.10.012. Epub 2018 Dec 22. |
| D012883 |
| Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |