Treatment for diabetic foot
| ISRCTN | ISRCTN29921809 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29921809 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Beijing Luhe Hospital Affiliated to Capital Medical University |
| Funder | Investigator initiated and funded |
- Submission date
- 07/10/2025
- Registration date
- 12/10/2025
- Last edited
- 07/10/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Diabetic foot disease is a serious complication of diabetes that can lead to poor blood flow in the legs and feet, making wounds difficult to heal and increasing the risk of amputation. This study looked at whether a new combination of treatments could improve outcomes for people with diabetic foot problems caused by narrowed arteries below the knee. Researchers compared two treatment approaches to see which worked better in helping wounds heal and reducing the need for further procedures or amputations.
Who can participate?
The study involved patients who were admitted to hospital with diabetic foot disease and had narrowed arteries below the knee.
What does the study involve?
Participants were divided into two groups. One group received a standard treatment using a drug-coated balloon to open up blocked arteries. The other group received a newer combination treatment that used a laser to remove blockages before using the drug-coated balloon. All participants were followed for one year to monitor their recovery and outcomes.
What are the possible benefits and risks of participating?
Patients in the study may benefit from more consistent treatment and follow-up care, which could lead to better healing and fewer complications. There were no specific risks reported for taking part in the study.
Where is the study run from?
The study was carried out in a hospital setting, starting when patients were admitted for diabetic foot treatment.
When is the study starting and how long is it expected to run for?
January 2022 to May 2024.
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Changbao Yan, 624934107@qq.com
Contact information
Public, Scientific, Principal investigator
No.82, Xinhuanan Road, Tongzhou District
Beijing
101100
China
 ORCID ID |
0000-0001-6770-5150 |
|---|---|
| Phone | +86 1069543901 |
| 624934107@qq.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective interventional non randomized |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Combined interventional treatment for diabetic foot with below-the-knee arterial lesions: a prospective cohort study |
| Study objectives | To evaluate the clinical effect of combined interventional therapy for diabetic foot (DF) with below-the-knee (BTK) arterial lesions. |
| Ethics approval(s) |
Approved 21/12/2021, Ethics Committee of Beijing Luhe Hospital (No.82, Xinhuanan Road, Tongzhou District, Beijing, 101100, China; +86 01069543901; luheyiyuan123@163.com), ref: 2021-LHKY-064-02 |
| Health condition(s) or problem(s) studied | Diabetic foot with below-the-knee arterial lesions |
| Intervention | A prospective cohort study was conducted of 138 patients with DF complicated with BTK arterial lesions. They were assigned to two groups: the control group was treated by drug-coated balloon angioplasty, while the experimental group underwent excimer laser ablation combined with drug-coated balloon angioplasty. All patients were followed up for 1 year. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Measured using patient records at 1 year: |
| Key secondary outcome measure(s) |
Measured using patient records at 1year: |
| Completion date | 31/05/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 58 Years |
| Upper age limit | 71 Years |
| Sex | All |
| Target sample size at registration | 152 |
| Total final enrolment | 138 |
| Key inclusion criteria | 1. DF ulcers of Wagner grades 1–4 2. Required lower extremity arterial interventional revascularization treatment. |
| Key exclusion criteria | 1. Non-ischemic diabetic foot 2. Unwilling to participate in the trial |
| Date of first enrolment | 01/01/2022 |
| Date of final enrolment | 31/05/2023 |
Locations
Countries of recruitment
- China
Study participating centre
Beijing
101100
China
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated duringand/oranalysedduring the current study will be available uponrequest from (Changbao Yan /Email: 624934107@qq.com) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
07/10/2025: Trial's existence confirmed by Ethics Committee of Beijing Luhe Hospital.
