Diabetic FootNCT06499506
Skew Flap vs Long Posterior Flap for Below Knee Amputation Early and Short- Term Outcomes
A study testing Below knee amputation in people with Diabetic Foot and Ischemic Leg, run by Sohag University at 1 site in Egypt.
Trial summary
Below knee amputations (BKAs) are frequently performed among vascular patients with end stage chronic limb threatening ischemia and / or complications of diabetes and diabetic foot infections and gangrene, It may also be necessary for patients with aggressive diabetic foot infections or gangrene, or both; for those… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Foot, Ischemic Leg
- What is being tested?
- Below knee amputation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2024to 1 Jan 2025
- 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 chronic atherosclerotic occlusive disease of the lower extremity and threatening limb ischemia (intractable rest pain, ulcer or gangrene) for whom all other treatment options failed or inapplicable .
- patients with aggressive diabetic foot infections or gangrene, or both.
- Patients with extensive venous ulceration.
- Patients following major trauma with unsalvageable limb.
- Patients with nonfunctioning damaged limb as in Charcot joint disease.
- Patients with extensive limb sepsis.
Who cannot join
- Patients with local site infection not candidate for instant closure.
- Patients with bad general condition.
Trial locations and contacts
1 site in 1 country.
About this study
Below knee amputations (BKAs) are frequently performed among vascular patients with end stage chronic limb threatening ischemia and / or complications of diabetes and diabetic foot infections and gangrene, It may also be necessary for patients with aggressive diabetic foot infections or gangrene, or both; for those with extensive venous ulceration; or following major trauma. and in the case of extremity sepsis.
There is two main methods for constructing the myocutaneous flaps in below knee amputation; the long posterior flap (LPF) and skew flap (SF).
Read the detailed description
Anesthesia BKA could be performed under general anesthesia (GA), epidural anesthesia or under spinal anesthesia .
Patient position The patient lies in the supine position. Technique The limb is prepared by an application of povidone iodine solution in the ward 2 h before surgery. The foot and any septic lesion is isolated. The whole limb is wrapped in a dry sterile sheet. Penicillin and metronidazole prophylaxis is used routinely.
The operation is performed under general anesthesia with a regional anesthetic technique.
The skin flaps are marked on the skin before any incision. And the skin flaps are semicircular. based on a line around the limb at right angles to its long axis, drawn at the plane of bone section 10-12cm from the joint line at the tibial plateau.
The skin flaps are cut which includes the fat and deep fascia. but these are not stripped from the underlying muscle more than is required to gain access to the anterior tibial compartment. The saphenous veins are ligated. The periosteum over the tibia is incised where it is exposed and elevated with the skin flap to 2 cm above the line of bone section.
The anterior tibial nerve and the peroneal nerve are divided and allowed to retract while the vessels are ligated. The fibula is divided 2cm above the line of tibial bone section.
The tibia is divided with a GIGLI saw. Traction on the bone hook exposes the tibialis posterior muscle and this is divided at the line of distal bone section which exposes the posterior tibial artery and its venae comitantes. the posterior tibial nerve and the peroneal artery and its venae comitantes. ligatures applied to each of the vascular bundles. The gastrocnemius and soleus muscle mass can then be separated from the tibia and fibula of the specimen while hemostasis is maintained. The muscle mass is cut transversely, thus freeing the specimen; this must allow a length of muscle below the bone end at least equal to the diameter of the leg.
The protruding muscle mass is then thinned from the line of bone section to its extremity .
Careful homeostasis is essential and the muscle must not be compressed due to too much bulk or tight constricting sutures.
A suction tube drain is drawn through the lateral aspect of the stump above the suture line and placed to collect any fluid in the vicinity of the bone ends.
The drain can be removed in 48-72 h; the sutures are removed at 15- 21 days. Follow up Patients will be followed up prospectively intraoperative, during postoperative hospital admission and late in outpatient clinic.
Major adverse clinical events (MACE) are carefully monitored. Follow up include immediate postoperative complications.
- Conditions
- Diabetic Foot, Ischemic Leg
- Being tested
- Below knee amputation
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Below knee amputationProcedure or surgery
trans tibial amputation one hand breadth below tibial tuberosity
| Study group | Role | What they receive |
|---|---|---|
| Skew Flap | Active comparator | skew Flap technique for below knee amputation Receives: Procedure: Below knee amputation |
| Long Posterior Flap | Active comparator | Long Posterior Flap for Below knee amputation Receives: Procedure: Below knee amputation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing
Primary stump healing, defined as a painless, healed suture line enabling fitting of a prosthetic limb (if appropriate) and regaining of mobility
Measured: 6 month
Re ampuation
Rate of reamputation at (a) same level; (b) higher level.
Measured: 1 month
Mobilization
Number of participants mobilizing with a prosthetic limb.
Measured: 6 month
Secondary outcomes (3)
Mortality
Thirty-day mortality rate.
Measured: 1 month
Hospital stay
Length of hospital stay.
Measured: 1 month
complaints
Symptoms relating to the stump, such as pain and swelling.
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start1 Jul 2024
- Primary completion1 Oct 2024
- Study completion1 Jan 2025
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 Sohag UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- comparison between Skew flap and long posterior flap for below knee amputation
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ibrahim Abdelmageed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499506
- Sponsor's protocol ID
- Soh-Med-24-06-15MS
- Status last verified
- Jun 2025
- First submitted
- 5 Jul 2024
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skew Flap vs Long Posterior Flap for Below Knee Amputation Early and Short- Term Outcomes
- ClinicalTrials.gov ID
- NCT06499506
- Acronym / sponsor ID
- Soh-Med-24-06-15MS
- Conditions
- Diabetic Foot, Ischemic Leg
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 12 Jul 2024 (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.
Below knee amputations (BKAs) are frequently performed among vascular patients with end stage chronic limb threatening ischemia and / or complications of diabetes and diabetic foot infections and gangrene, It may also be necessary for patients with aggressive diabetic foot infections or gangrene, or both; for those with extensive venous ulceration; or following major trauma. and in the case of extremity sepsis.
There is two main methods for constructing the myocutaneous flaps in below knee amputation; the long posterior flap (LPF) and skew flap (SF).
Detailed description
Anesthesia BKA could be performed under general anesthesia (GA), epidural anesthesia or under spinal anesthesia .
Patient position The patient lies in the supine position. Technique The limb is prepared by an application of povidone iodine solution in the ward 2 h before surgery. The foot and any septic lesion is isolated. The whole limb is wrapped in a dry sterile sheet. Penicillin and metronidazole prophylaxis is used routinely.
The operation is performed under general anesthesia with a regional anesthetic technique.
The skin flaps are marked on the skin before any incision. And the skin flaps are semicircular. based on a line around the limb at right angles to its long axis, drawn at the plane of bone section 10-12cm from the joint line at the tibial plateau.
The skin flaps are cut which includes the fat and deep fascia. but these are not stripped from the underlying muscle more than is required to gain access to the anterior tibial compartment. The saphenous veins are ligated. The periosteum over the tibia is incised where it is exposed and elevated with the skin flap to 2 cm above the line of bone section.
The anterior tibial nerve and the peroneal nerve are divided and allowed to retract while the vessels are ligated. The fibula is divided 2cm above the line of tibial bone section.
The tibia is divided with a GIGLI saw. Traction on the bone hook exposes the tibialis posterior muscle and this is divided at the line of distal bone section which exposes the posterior tibial artery and its venae comitantes. the posterior tibial nerve and the peroneal artery and its venae comitantes. ligatures applied to each of the vascular bundles. The gastrocnemius and soleus muscle mass can then be separated from the tibia and fibula of the specimen while hemostasis is maintained. The muscle mass is cut transversely, thus freeing the specimen; this must allow a length of muscle below the bone end at least equal to the diameter of the leg.
The protruding muscle mass is then thinned from the line of bone section to its extremity .
Careful homeostasis is essential and the muscle must not be compressed due to too much bulk or tight constricting sutures.
A suction tube drain is drawn through the lateral aspect of the stump above the suture line and placed to collect any fluid in the vicinity of the bone ends.
The drain can be removed in 48-72 h; the sutures are removed at 15- 21 days. Follow up Patients will be followed up prospectively intraoperative, during postoperative hospital admission and late in outpatient clinic.
Major adverse clinical events (MACE) are carefully monitored. Follow up include immediate postoperative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- comparison between Skew flap and long posterior flap for below knee amputation
| Arm | Type | Receives |
|---|---|---|
| Skew Flap | Active comparator | Procedure: Below knee amputationskew Flap technique for below knee amputation |
| Long Posterior Flap | Active comparator | Procedure: Below knee amputationLong Posterior Flap for Below knee amputation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with chronic atherosclerotic occlusive disease of the lower extremity and threatening limb ischemia (intractable rest pain, ulcer or gangrene) for whom all other treatment options failed or inapplicable .
- patients with aggressive diabetic foot infections or gangrene, or both.
- Patients with extensive venous ulceration.
- Patients following major trauma with unsalvageable limb.
- Patients with nonfunctioning damaged limb as in Charcot joint disease.
Key exclusion criteria (2 listed)
- Patients with local site infection not candidate for instant closure.
- Patients with bad general condition.
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 |
|---|---|---|
| Below knee amputationtrans tibial amputation one hand breadth below tibial tuberosity | Procedure or surgery | Long Posterior Flap, Skew Flap |
Primary outcome
Healing
Time frame: 6 month
Primary stump healing, defined as a painless, healed suture line enabling fitting of a prosthetic limb (if appropriate) and regaining of mobility
Re ampuation
Time frame: 1 month
Rate of reamputation at (a) same level; (b) higher level.
Mobilization
Time frame: 6 month
Number of participants mobilizing with a prosthetic limb.
3 secondary outcomes
Mortality
Time frame: 1 month
Hospital stay
Time frame: 1 month
complaints
Time frame: 2 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Below knee amputation in people with Diabetic Foot and Ischemic Leg, run by Sohag University at 1 site in Egypt.
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 6 inclusion and 2 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: finished, as of the sponsor's last update on 26 Jun 2025. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing (time frame: 6 month). The study lists 3 primary outcomes in all. 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 26 Jun 2025.