Wound Bed Preparation for Diabetic Foot Ulcers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2022-12-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study objective was to compare the efficacy of NPWT versus alginates dressings on the wound bed preparation prior to STSG surgery, as well as investigating the underlying mechanisms.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sterile Wound Care Liquid Dressing in Treatment of Diabetic Ulcer in Necrosis Stable Stage: a Randomized Control Trial

NCT05975827

Diabetic Ulcers Diabetic Ulcers in Necrosis Stable Stage

NOT_YET_RECRUITING NA

Negative Pressure Wound Therapy in the Management of Diabetic Foot Ulcers

NCT04093635

Diabetic Foot Ulcer

UNKNOWN

Comparative Study of Antibacterial Effect on Silver Dressing of Negative Pressure Wound

NCT02274207

Diabetes Mellitus

UNKNOWN PHASE4

The Study of Wound Dressings for Portable NPWT

NCT03135964

Pressure Ulcer Diabetic Foot Ulcer

COMPLETED NA

Comparison Between Negative Pressure Wound Therapy and Conventional Wound Dressings Before and After Split-Thickness Skin Grafting in Diabetic Foot Wounds

NCT05716503

Negative-Pressure Wound Therapy Diabetic Foot

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The diabetic foot ulcers (DFUs) are major complications of patients with diabetes mellitus. Split thickness skin graft (STSG) surgery is a cost-effective method for the rapid healing of DFUs. The aim of this study was to compare the efficacy of negative pressure wound therapy (NPWT) using vacuum-assisted closure (VAC) device versus conventional moist dressings (alginates) on the wound bed preparation prior to STSG surgery for patients with chronic DFUs.

This ia a prospective, randomized controlled trial. All the patients were randomly divided into two groups: the NPWT group or the control group. Once the DFUs wound was filled with healthy granulation tissues, STSG surgery was performed. The primary endpoint included the time to STSG surgery (the duration from first surgical debridement to STSG surgery). The secondary endpoints included the survival rates of skin graft, the wound blood perfusion, the wound neutrophil extracellular traps (NETs) formation, and polarization of M1 or M2 macrophages in the DFUs wounds of the two groups.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Foot

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The patients with diabetic foot ulcers (DFUs)

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

the NPWT group

For patients in the NPWT group, the wound bed preparation was facilitated by VAC device.

Group Type EXPERIMENTAL

Negative pressure wound therapy (NPWT)

Intervention Type PROCEDURE

For patients in the NPWT group, the wound bed preparation was facilitated by vacuum-assisted closure (VAC).

the control group

For patients in the control group, the wound bed preparation was facilitated by alginates dressing change method.

Group Type ACTIVE_COMPARATOR

conventional moist dressings

Intervention Type PROCEDURE

For patients in the control group, the wound bed preparation was facilitated by conventional dressing change method (with alginates ).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Negative pressure wound therapy (NPWT)

For patients in the NPWT group, the wound bed preparation was facilitated by vacuum-assisted closure (VAC).

Intervention Type PROCEDURE

conventional moist dressings

For patients in the control group, the wound bed preparation was facilitated by conventional dressing change method (with alginates ).

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients with DFUs aged 20-80 years.
2. Wagner grade 2 to 3.
3. Chronic DFUs wounds (duration of disease ≥ 2 weeks).
4. Ankle brachial ratio (ABI) 0.5～0.9, wound area 8\~20 cm2.

Exclusion Criteria

1. Patients who were unable to complete the follow-up were not included,
2. Pregnant or nursing mothers were not included.
3. Patients with foot ulcers other than diabetes, peripheral vascular disease, organ dysfunctions (heart failure, respiratory failure, liver dysfunction, renal impairment or intestinal failure), or autoimmune diseases (rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, Sjogren's syndrome, connective tissues disease or systemic vasculitis) were not included.
4. Patients who received growth factors or hyperbaric oxygen therapies for the DFUs wounds within one month were not included.
5. Patients who had medications (such as corticosteroids, immunosuppressive agents or chemotherapy) within six months were not included.

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No