Slow-release Tb4 Collagen and Chitosan Porous Sponge Scaffolds Skin Substitute Treatment is Difficult to Heal Wounds

Slow-release Tb4 Collagen and Chitosan Porous Sponge Scaffolds Skin Substitutes Treatment of Difficult to Heal Wounds Single-center Randomized Parallel Controlled Clinical Studies

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02668055

Acronym

TB4

Enrollment

Registered

2016-01-29

Start date

2012-01-31

Completion date

2015-12-31

Last updated

2016-01-29

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

Conditions

Wounds

Keywords

TB4, Difficult to heal

Brief summary

Evaluation of slow-release Tb4 collagen and chitosan porous sponge scaffolds skin substitutes the effectiveness of clinical trials for the treatment of difficult to heal wounds and security.

Interventions

BIOLOGICALTB4

Computing area was in proportion to the slow-release Tb4 collagen and chitosan porous sponge scaffolds skin substitute cells stick in the wound surface

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

17 Years to 78 Years

Healthy volunteers

Yes

Inclusion criteria

1. Meet difficult had 1 month or more to heal the wound patients 2. Who signed the informed consent of men or women older than 17 (pregnancy) 3. Has the ability to care for, has the ability to self signed informed consent, 7 to 17 years old must be signed by the guardian informed consent 4. The process of mental stability, can finish the test

Exclusion criteria

1. Known allergic to bovine collagen or gao min physique 2. the wound is greater than the10cm×10cm 3. People with mental illness, drug abusers and or other items 4. Pregnant women,Prepare a pregnancy or breast feeding women 5.3 months participated in other similar experiment 6.Serious infectious disease not controller 7.With surgery, such as severe trauma stress situation 8.Can not meet the requirement of the long-term follow-up of patients

Design outcomes

Primary

Measure	Time frame	Description
Frequency of Adverse Events	6 months	Tb4 collagen- chitosan porous sponge scaffolds skin substitute rate of wound healing, and healing

Secondary

Measure	Time frame	Description
Relative Wound Area Regression of 40% of More at 6 Week	6week	Subsistence the wound tissue(4 mm ×4 mm) biopsy samples, to determine the wound repair

Countries

China

Outcome results

None listed

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