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CompletedNCT06499506Updated Jun 26, 2025

Skew Flap vs Long Posterior Flap for Below Knee Amputation Early and Short- Term Outcomes

An interventional study of Below knee amputation in Diabetic Foot and Ischemic Leg, sponsored by Sohag University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2025-06-26.

Sponsored by Sohag University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Sex
All
01

Study 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 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.

02

Conditions studied

  • Diabetic Foot
  • Ischemic Leg

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03

In context

Diabetic Foot

1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 826 interventional studies indexed under Diabetic Foot.

Browse Diabetic Foot studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Patients with local site infection not candidate for instant closure.
  • Patients with bad general condition.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Skew Flap

    skew Flap technique for below knee amputation

    Procedure: Below knee amputation

  • Active comparator
    Long Posterior Flap

    Long Posterior Flap for Below knee amputation

    Procedure: Below knee amputation

Interventions

  • ProcedureBelow knee amputation

    trans tibial amputation one hand breadth below tibial tuberosity

06

What researchers measure

Primary outcomes

  1. Healing

    Primary stump healing, defined as a painless, healed suture line enabling fitting of a prosthetic limb (if appropriate) and regaining of mobility

    Time frame: 6 month

  2. Re ampuation

    Rate of reamputation at (a) same level; (b) higher level.

    Time frame: 1 month

  3. Mobilization

    Number of participants mobilizing with a prosthetic limb.

    Time frame: 6 month

Secondary outcomes

  1. Mortality

    Thirty-day mortality rate.

    Time frame: 1 month

  2. Hospital stay

    Length of hospital stay.

    Time frame: 1 month

  3. complaints

    Symptoms relating to the stump, such as pain and swelling.

    Time frame: 2 month

07

Study locations

1 site
  • Sohag University Hospital
    Sohag, 82511, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06499506
Lead sponsor
Sohag University
Responsible party
Mohamed Ibrahim Abdelmageed (Ibrahim, Sohag University) — Principal investigator
First posted
Jul 12, 2024
Start date
Jul 1, 2024
Primary completion
Oct 1, 2024
Completion
Jan 1, 2025
Last update
Jun 26, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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