Diabetic FootNCT04709887
Appropriate Strategy of Surgical Treatment in Ischemic Diabetic Foot
A study testing Wound treatment, Vascular intervention surgery and Tibial transverse transport surgery in people with Diabetic Foot and Ischemic Diabetic Foot Ulcer, run by Peking University People's Hospital at 1 site in China.
Trial summary
This cohort study aims to evaluate the outcomes of appropriate surgical treatment strategies in diabetic foot ulcers with different rate of popliteal artery stenosis(<50% or ≥50%). In this study, patients with Texas university grade 2-4(stage C-D) ischemic diabetic foot ulcers will be included. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Foot, Ischemic Diabetic Foot Ulcer, Popliteal Artery Stenosis
- What is being tested?
- Wound treatment, Vascular intervention surgery and Tibial transverse transport surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2017to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with diabetic foot, according to "Chinese Guidelines for Diagnosis and Treatment of Diabetic Foot (2017)".
- Texas university grade 2-4(stage C-D) ischemic diabetic foot ulcers.
- Have clear consciousness, not suffer from mental illness, can cooperate in research and treatment.
- Patients who are informed, participate in the research voluntarily, and have signed the informed consent.
- Have complete clinical data.
Who cannot join
- Patients with severe systemic infection, who need to be amputated immediately to save lives.
- Patients with mental illness, who cannot cooperate to complete the adjustment and nursing of the external fixator.
- Patients with severe cardiovascular and cerebrovascular diseases (such as severe cardiac insufficiency, severe sequelae of cerebrovascular disease), or with acute infectious diseases.
- Have used or using glucocorticoids systemically within 3 months before admission.
- Have participated in other medical clinical trials within 3 months before admission.
- Patients with severe liver or kidney function abnormalities
- Pregnant or lactating women.
- Patients who lost follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing
Hailin Xu, MD
About this study
This cohort study aims to evaluate the outcomes of appropriate surgical treatment strategies in diabetic foot ulcers with different rate of popliteal artery stenosis(<50% or ≥50%). In this study, patients with Texas university grade 2-4(stage C-D) ischemic diabetic foot ulcers will be included. Data of patients who underwent surgical treatment in the past will be retrospectively collected. The patients with follow-up time less than 12 months will continue to follow up. Also the postoperative patients will be prospectively collected. Effects of different surgical strategies, including wound healing therapy, interventional therapy and tibial transverse bone transport therapy will be measured by several indexes.
- Being tested
- Wound treatment, Vascular intervention surgery, Tibial transverse transport surgery
- Keywords
- Ischemic Diabetic Foot Ulcer, Surgical Strategy, Cohort study
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wound treatmentProcedure or surgery
According to the guidelines and recommendations of the International Diabetic Foot Working Group, ulcer surface debridement, negative pressure suction drainage, and routine dressing were performed until the wound healed or the end of the trial.
Vascular intervention surgeryProcedure or surgery
Segmented distal angiography under the guidance of digital subtraction angiography (DSA) were perform after local anesthesia. The superficial artery is expanded by a 3-4 mm balloon.
Tibial transverse transport surgeryProcedure or surgery
In the anteromedial area of the proximal tibia of the affected limb, the external fixation frame was compared with the area along the midline of the medial longitudinal axis of the proximal tibia. Subsequently, two 3.0 Steinmann pins were inserted through the single layer of cortical bone. The skin was cut along the long axis with the 3.0 Steinmann pin as the centre, and the subcutaneous tissue was separate bluntly to expose the periosteum. The Steinmann pins were used as the centre point for the drilling on four sides with a 2.0 drill bit and use of a rapid osteotomy device; the length of each side was 2.5 cm. Subperiosteal osteotomy was performed with a 5-mm narrow bone knife at an angle of 15°-30° to the bone surface. The surgeons should pay attention to protect the blood supply of the periosteum during this procedure. The external fixators were fixed with 4.0 Steinmann pins at the distal and proximal ends. The subcutaneous tissue and skin were sutured.
| Study group | Role | What they receive |
|---|---|---|
| Rate of popliteal artery stenosis < 50%, W. | Other | If the rate of popliteal artery stenosis of patients < 50%, the patients only receive the wound treatment. Receives: Procedure: Wound treatment |
| Rate of popliteal artery stenosis < 50%, WT. | Other | If the rate of popliteal artery stenosis of patients < 50%, the patients receive the wound treatment and tibial transverse transport surgery. Receives: Procedure: Wound treatment; Procedure: Tibial transverse transport surgery |
| Rate of popliteal artery stenosis ≥ 50%, WV. | Other | If the rate of popliteal artery stenosis of patients ≥ 50%, the patients receive the wound treatment and vascular intervention surgery. Receives: Procedure: Wound treatment; Procedure: Vascular intervention surgery |
| Rate of popliteal artery stenosis ≥ 50%, WT. | Other | If the rate of popliteal artery stenosis of patients ≥ 50%, the patients receive the wound treatment and tibial transverse transport surgery. Receives: Procedure: Wound treatment; Procedure: Tibial transverse transport surgery |
| Rate of popliteal artery stenosis ≥ 50%, WVT. | Other | If the rate of popliteal artery stenosis of patients ≥ 50%, the patients receive the wound treatment, vascular intervention and tibial transverse transport surgery. Receives: Procedure: Wound treatment; Procedure: Vascular intervention surgery; Procedure: Tibial transverse transport surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing rate of wound surface
Measured: 12 months after surgical operation
Secondary outcomes (3)
Ankle-brachial index
Measured: 3 months after surgical operation
Ankle-brachial index
Measured: 12 months after surgical operation
Recurrence rate of foot ulcer
Measured: 12 months after surgical operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start1 Jan 2017
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hailin Xu, Peking University People's Hospital
- Investigators
- Hailin Xu, MD, Study director, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709887
- Sponsor's protocol ID
- mTTTDFU01
- Status last verified
- Jan 2021
- First submitted
- 12 Jan 2021
- Last updated
- 19 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appropriate Strategy of Surgical Treatment in Ischemic Diabetic Foot
- ClinicalTrials.gov ID
- NCT04709887
- Acronym / sponsor ID
- mTTTDFU01
- Keywords
- Ischemic Diabetic Foot Ulcer, Surgical Strategy, Cohort study
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 332 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 14 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This cohort study aims to evaluate the outcomes of appropriate surgical treatment strategies in diabetic foot ulcers with different rate of popliteal artery stenosis(<50% or ≥50%). In this study, patients with Texas university grade 2-4(stage C-D) ischemic diabetic foot ulcers will be included. Data of patients who underwent surgical treatment in the past will be retrospectively collected. The patients with follow-up time less than 12 months will continue to follow up. Also the postoperative patients will be prospectively collected. Effects of different surgical strategies, including wound healing therapy, interventional therapy and tibial transverse bone transport therapy will be measured by several indexes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Rate of popliteal artery stenosis < 50%, W. | Other | Procedure: Wound treatmentIf the rate of popliteal artery stenosis of patients < 50%, the patients only receive the wound treatment. |
| Rate of popliteal artery stenosis < 50%, WT. | Other | Procedure: Wound treatment, Procedure: Tibial transverse transport surgeryIf the rate of popliteal artery stenosis of patients < 50%, the patients receive the wound treatment and tibial transverse transport surgery. |
| Rate of popliteal artery stenosis ≥ 50%, WV. | Other | Procedure: Wound treatment, Procedure: Vascular intervention surgeryIf the rate of popliteal artery stenosis of patients ≥ 50%, the patients receive the wound treatment and vascular intervention surgery. |
| Rate of popliteal artery stenosis ≥ 50%, WT. | Other | Procedure: Wound treatment, Procedure: Tibial transverse transport surgeryIf the rate of popliteal artery stenosis of patients ≥ 50%, the patients receive the wound treatment and tibial transverse transport surgery. |
| Rate of popliteal artery stenosis ≥ 50%, WVT. | Other | Procedure: Wound treatment, Procedure: Vascular intervention surgery, Procedure: Tibial transverse transport surgeryIf the rate of popliteal artery stenosis of patients ≥ 50%, the patients receive the wound treatment, vascular intervention and tibial transverse transport surgery. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with diabetic foot, according to "Chinese Guidelines for Diagnosis and Treatment of Diabetic Foot (2017)".
- Texas university grade 2-4(stage C-D) ischemic diabetic foot ulcers.
- Have clear consciousness, not suffer from mental illness, can cooperate in research and treatment.
- Patients who are informed, participate in the research voluntarily, and have signed the informed consent.
- Have complete clinical data.
Key exclusion criteria (8 listed)
- Patients with severe systemic infection, who need to be amputated immediately to save lives.
- Patients with mental illness, who cannot cooperate to complete the adjustment and nursing of the external fixator.
- Patients with severe cardiovascular and cerebrovascular diseases (such as severe cardiac insufficiency, severe sequelae of cerebrovascular disease), or with acute infectious diseases.
- Have used or using glucocorticoids systemically within 3 months before admission.
- Have participated in other medical clinical trials within 3 months before admission.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wound treatmentAccording to the guidelines and recommendations of the International Diabetic Foot Working Group, ulcer surface debridement, negative pressure suction drainage, and routine dressing were performed until the wound healed or the end of the trial. | Procedure or surgery | Rate of popliteal artery stenosis < 50%, W., Rate of popliteal artery stenosis < 50%, WT., Rate of popliteal artery stenosis ≥ 50%, WT., Rate of popliteal artery stenosis ≥ 50%, WV., Rate of popliteal artery stenosis ≥ 50%, WVT. |
| Vascular intervention surgerySegmented distal angiography under the guidance of digital subtraction angiography (DSA) were perform after local anesthesia. The superficial artery is expanded by a 3-4 mm balloon. | Procedure or surgery | Rate of popliteal artery stenosis ≥ 50%, WV., Rate of popliteal artery stenosis ≥ 50%, WVT. |
| Tibial transverse transport surgeryIn the anteromedial area of the proximal tibia of the affected limb, the external fixation frame was compared with the area along the midline of the medial longitudinal axis of the proximal tibia. Subsequently, two 3.0 Steinmann pins were inserted through the single layer of cortical bone. The skin was cut along the long axis with the 3.0 Steinmann pin as the centre, and the subcutaneous tissue was separate bluntly to expose the periosteum. The Steinmann pins were used as the centre point for the drilling on four sides with a 2.0 drill bit and use of a rapid osteotomy device; the length of each side was 2.5 cm. Subperiosteal osteotomy was performed with a 5-mm narrow bone knife at an angle of 15°-30° to the bone surface. The surgeons should pay attention to protect the blood supply of the periosteum during this procedure. The external fixators were fixed with 4.0 Steinmann pins at the distal and proximal ends. The subcutaneous tissue and skin were sutured. | Procedure or surgery | Rate of popliteal artery stenosis < 50%, WT., Rate of popliteal artery stenosis ≥ 50%, WT., Rate of popliteal artery stenosis ≥ 50%, WVT. |
Primary outcome
Healing rate of wound surface
Time frame: 12 months after surgical operation
3 secondary outcomes
Ankle-brachial index
Time frame: 3 months after surgical operation
Ankle-brachial index
Time frame: 12 months after surgical operation
Recurrence rate of foot ulcer
Time frame: 12 months after surgical operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hailin Xu, MD study director
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wound treatment, Vascular intervention surgery and Tibial transverse transport surgery in people with Diabetic Foot and Ischemic Diabetic Foot Ulcer, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yusong Yuan, Master (+86 18801229862, xiaxi@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing rate of wound surface (time frame: 12 months after surgical operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2021.