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A Trial to Evaluate the Combination Efficacy of Artificial Dermis and Growth Factor in Chronic Wounds Ulcer

18. oktober 2019 opdateret af: Second Affiliated Hospital, School of Medicine, Zhejiang University

A Randomized, Open-label, Multicenter Clinical Trial to Evaluate the Combination Efficacy of Double-layer Artificial Dermis and Growth Factor in the Treatment of Chronic Wounds Ulcer

Double layer artificial dermis repair material has been widely used in scar plastic, burn, trauma, chronic wounds and other aspects of wound repair and reconstruction. In the course of clinical application, we found that for chronic wounds, the combination of artificial dermis and growth factor can shorten the wound healing cycle, and have a positive impact on the economy and psychology of patients. In order to verify this effect, we plan to carry out this study to evaluate whether double-layer artificial dermis repair material combined with growth factor treatment can improve wound closure rate and shorten closure cycle compared with single artificial dermis for chronic wound.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

64

Fase

  • Ikke anvendelig

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Patients diagnosed as chronic wounds ulcer;
  2. The affected limb has sufficient blood perfusion. The ankle brachial index was 0.65-1.3, or the partial pressure of oxygen was more than 40 mmHg, or Doppler ultrasound showed enough blood flow.
  3. After debridement, the distance between the wound and the edge of other ulcers was >2cm.
  4. After debridement, the area of exposed bone or tendon was >4cm2.
  5. The wound was completely debridement without obvious necrosis, infection control or osteomyelitis control.
  6. The duration of ulcer wound was at least 30 days.
  7. Sign the informed consent voluntarily.

Exclusion Criteria:

  1. Poor control of diabetes (fasting blood glucose ≥ 8.0mmol/l, HbA1c ≥ 12%);
  2. The researchers think that there are factors affecting wound healing, such as the use of corticosteroids, immunosuppressants and other drugs, chemotherapy or radiotherapy within one year.
  3. To receive or plan to receive drugs or treatment, the researchers believe that these drugs or treatment will interfere with or affect the speed and quality of wound healing;
  4. Unstable Charcot's foot or Charcot's joint disease with bone protrusion;
  5. Patients with severe lymphedema, coagulation disorders, autoimmune diseases, cardiovascular and cerebrovascular diseases, and severe hepatopulmonary and renal diseases;
  6. Those who have received hyperbaric oxygen treatment within 5 days before enrollment, or who have received or plan to receive growth factor, tissue-engineered skin or other skin substitutes treatment within 30 days;
  7. Those who have participated in or are participating in other clinical studies within 30 days before screening;
  8. Pregnant, or lactating women;
  9. Poor general condition or other conditions not suitable for the use of double-layer artificial leather repair materials;
  10. Be allergic to collagen or chondroitin sulfate;
  11. Other cases that researchers think are not suitable for the participation.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: artificial dermis with growth factor
Enhed: artificial dermis
artificial dermis will be used after fully debridement of the wound
Andet: growth factor
growth factor
Eksperimentel: artificial dermis only
Enhed: artificial dermis
artificial dermis will be used after fully debridement of the wound

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
average closure time
Tidsramme: From the beginning of the treatment period to the time when the survival rate of skin grafting reaches 100% or 12 weeks visit (whichever comes first), record the average time when all the subjects who reach the complete closure of the wound
From the beginning of the treatment period to the time when the survival rate of skin grafting reaches 100% or 12 weeks visit (whichever comes first), record the average time when all the subjects who reach the complete closure of the wound

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
total wound closure rate
Tidsramme: From the beginning of the treatment period to the survival rate of skin grafting reaching 100% or 12 weeks visit (whichever comes first), record the total number of patients who have reached the complete closure of the wound during this period
The total wound closure rate = (the number of patients who achieved complete wound closure within 12 weeks / the total number of patients in the group) * 100%.
From the beginning of the treatment period to the survival rate of skin grafting reaching 100% or 12 weeks visit (whichever comes first), record the total number of patients who have reached the complete closure of the wound during this period

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. marts 2020

Primær færdiggørelse (Forventet)

28. februar 2022

Studieafslutning (Forventet)

30. juni 2022

Datoer for studieregistrering

Først indsendt

17. oktober 2019

Først indsendt, der opfyldte QC-kriterier

18. oktober 2019

Først opslået (Faktiske)

21. oktober 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. oktober 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. oktober 2019

Sidst verificeret

1. oktober 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • QK-MP-201903

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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