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

NCT06499506 | Completed

• 1 other identifier: Soh-Med-24-06-15MS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Diabetic Foot; Ischemic Leg

Outcome Measures

Primary Outcomes (3)

• Healing

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

  6 month

• Re ampuation

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

  1 month

• Mobilization

  Number of participants mobilizing with a prosthetic limb.

  6 month

Secondary Outcomes (3)

• Mortality

  1 month

• Hospital stay

  1 month

• complaints

  2 month

Study Arms (2)

Skew Flap

ACTIVE COMPARATOR

skew Flap technique for below knee amputation

Procedure: Below knee amputation

Long Posterior Flap

ACTIVE COMPARATOR

Long Posterior Flap for Below knee amputation

Procedure: Below knee amputation

Interventions

Below knee amputation PROCEDURE

trans tibial amputation one hand breadth below tibial tuberosity

Long Posterior Flap; Skew Flap

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, 82511, Egypt

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ibrahim

Model Details: comparison between Skew flap and long posterior flap for below knee amputation

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 12, 2024
• Study Start: July 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: January 1, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Locations

EG (1)